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From Health Canada


Manufacturer

BTNX INC.
722 Rosebank Rd.
Pickering, ON, CA, L1W 4B2

Company ID: 118449

Licence No.: 65333

Type: Test Kit
Device class: 2
Device first issue date 2004-08-03
Licence name: HCG PREGNANCY TEST (URINE AND SERUM)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-12-15 RAPID RESPONSE PREGNANCY COMBO TEST CASSETTE 2023-12-15 HCG-3C25
2023-12-15 HCG-3C50
2023-12-15 RAPID RESPONSE PREGNANCY COMBO TEST STRIP 2023-12-15 HCG-3S100
2023-12-15 HCG-3S50

Licence No.: 65334

Type: Test Kit
Device class: 2
Device first issue date 2004-08-03
Licence name: HCG PREGNANCY TEST (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-12-15 RAPID RESPONSE MIDSTREAM PREGNANCY TEST 2023-12-15 HCG-1M1
2023-12-15 UR-PM-HCG-01
2023-12-15 RAPID RESPONSE PREGNANCY TEST CASSETTE 2023-12-15 HCG-1C25
2023-12-15 HCG-1C50
2023-12-15 RAPID RESPONSE PREGNANCY TEST STRIP 2023-12-15 HCG-1S100
2023-12-15 HCG-1S50

Licence No.: 65335

Type: Test Kit
Device class: 2
Device first issue date 2004-08-03
Licence name: LH OVULATION TEST (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2004-08-03 LH OVULATION TEST CASSETTE (URINE) 2014-10-16 LH-1C-07
2004-08-03 LH OVULATION TEST STRIP (URINE) 2014-10-16 LH-1S-07
2004-08-03 MIDSTREAM OVULATION TEST (URINE) 2014-10-16 LH-1M-07
2014-10-16 EASY CONCEPTION LH TEST CASSETTE (URINE) 2014-10-16 LH-1C-07-EC

Licence No.: 70759

Type: Device Family
Device class: 2
Device first issue date 2006-03-10
Licence name: ACON URINALYSIS REAGENT STRIPS (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2006-03-10 URINALYSIS REAGENT STRIPS (1 PARAMETER) 2006-03-10 U031-011
2006-03-10 URINALYSIS REAGENT STRIPS (10 PARAMETERS) 2006-03-10 U031-101
2006-03-10 URINALYSIS REAGENT STRIPS (11 PARAMETERS) 2006-03-10 U031-111
2006-03-10 URINALYSIS REAGENT STRIPS (2 PARAMETERS) 2006-03-10 U031-021
2006-03-10 URINALYSIS REAGENT STRIPS (3 PARAMETERS) 2006-03-10 U031-031
2006-03-10 URINALYSIS REAGENT STRIPS (4 PARAMETERS) 2006-03-10 U031-041
2006-03-10 URINALYSIS REAGENT STRIPS (5 PARAMETERS) 2006-03-10 U031-051
2006-03-10 URINALYSIS REAGENT STRIPS (6 PARAMETERS) 2006-03-10 U031-061
2006-03-10 URINALYSIS REAGENT STRIPS (7 PARAMETERS) 2006-03-10 U031-071
2006-03-10 URINALYSIS REAGENT STRIPS (8 PARAMETERS) 2006-03-10 U031-081
2006-03-10 URINALYSIS REAGENT STRIPS (9 PARAMETERS) 2006-03-10 U031-091
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (1 PARAMETER) 2006-04-03 U031-015
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (10 PARAMETERS) 2006-04-03 U031-105
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (11 PARAMETERS) 2006-04-03 U031-115
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (2 PARAMETERS) 2006-04-03 U031-025
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (3 PARAMETERS) 2006-04-03 U031-035
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (4 PARAMETERS) 2006-04-03 U031-045
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (5 PARAMETERS) 2006-04-03 U031-055
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (6 PARAMETERS) 2006-04-03 U031-065
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (7 PARAMETERS) 2006-04-03 U031-075
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (8 PARAMETERS) 2006-04-03 U031-085
2006-04-03 INSIGHT URINALYSIS REAGENT STRIPS (9 PARAMETERS) 2006-04-03 U031-095
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (1 PARAMETER) 2006-04-03 U031-011
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (10 PARAMETERS) 2006-04-03 U031-101
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (11 PARAMETERS) 2006-04-03 U031-111
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (2 PARAMETERS) 2006-04-03 U031-021
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (3 PARAMETERS) 2006-04-03 U031-031
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (4 PARAMETERS) 2006-04-03 U031-041
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (5 PARAMETERS) 2006-04-03 U031-051
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (6 PARAMETERS) 2006-04-03 U031-061
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (7 PARAMETERS) 2006-04-03 U031-071
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (8 PARAMETERS) 2006-04-03 U031-081
2006-04-03 MISSION URINALYSIS REAGENT STRIPS (9 PARAMETERS) 2006-04-03 U031-091
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 1 PARAMETER 2010-01-07 U031-016
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 10 PARAMETERS 2010-01-07 U031-106
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 11 PARAMETERS 2010-01-07 U031-116
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 2 PARAMETERS 2010-01-07 U031-026
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 3 PARAMETERS 2010-01-07 U031-036
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 4 PARAMETERS 2010-01-07 U031-046
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 5 PARAMETERS 2010-01-07 U031-056
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 6 PARAMETERS 2010-01-07 U031-066
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 7 PARAMETERS 2010-01-07 U031-076
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 8 PARAMETERS 2010-01-07 U031-086
2010-01-07 DISTINCT URINALYSIS REAGENT STRIPS - 9 PARAMETERS 2010-01-07 U031-096
2013-02-11 INSIGHT URINALYSIS REAGENT STRIPS (13 PARAMETERS ) 2013-02-11 U031-135
2013-02-11 INSIGHT URINALYSIS REAGENT STRIPS (14 PARAMETERS ) 2013-02-11 U031-145
2013-02-11 MISSION URINALYSIS REAGENT STRIPS (13 PARAMETERS ) 2013-02-11 U031-131
2013-02-11 MISSION URINALYSIS REAGENT STRIPS (14 PARAMETERS ) 2013-02-11 U031-141

Licence No.: 71494

Type: Device Family
Device class: 2
Device first issue date 2006-06-01
Licence name: U120 URINE ANALYZERS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2006-06-01 INSIGHT U120 URINE ANALYZER 2006-06-01 REF U111-105
2006-06-01 MISSION U120 URINE ANALYZER 2006-06-01 REF U111-101
2008-12-08 INSIGHT U120 URINE ANALYZER WITH BARCODE READER 2008-12-08 U111-115
2008-12-08 MISSION U120 URINE ANALYZER WITH BARCODE READER 2008-12-08 U111-111
2008-12-08 VERIFY U120 URINE ANALYZER 2008-12-08 U111-102
2008-12-08 VERIFY U120 URINE ANALYZER WITH BARCODE READER 2008-12-08 U111-112

Licence No.: 77961

Type: Test Kit
Device class: 2
Device first issue date 2008-09-17
Licence name: RAPID RESPONSE FSH MENOPAUSE TEST CASSETTE (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2008-09-17 RAPID RESPONSE FSH MENOPAUSE TEST CASSETTE (URINE) 2008-09-17 FSH-1C25
2008-09-17 FSH-1C50

Licence No.: 78596

Type: Device Family
Device class: 2
Device first issue date 2008-12-05
Licence name: U500 URINE ANALYZER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2008-12-05 INSIGHT U500 URINE ANALYZER 2008-12-05 U211-105
2008-12-05 INSIGHT U500 URINE ANALYZER WITH BARCODE READER 2008-12-05 U211-115
2008-12-05 MISSION U500 URINE ANALYZER 2008-12-05 U211-101
2008-12-05 MISSION U500 URINE ANALYZER WITH BARCODE READER 2008-12-05 U211-111
2008-12-05 VERIFY U500 URINE ANALYZER 2008-12-05 U211-102
2008-12-05 VERIFY U500 URINE ANALYZER WITH BARCODE READER 2008-12-05 U211-112

Licence No.: 79349

Type: Test Kit
Device class: 2
Device first issue date 2009-03-23
Licence name: RAPID RESPONSE ALCOHOL SALIVA TEST

Device details
Device first issue date Device name Identifier first issue date Device identifier
2009-03-23 RAPID RESPONSE ALCOHOL SALIVA TEST 2009-03-23 AST-2S1
2009-03-23 AST-2S25
2020-08-17 AST-2S50

Licence No.: 80244

Type: Test Kit
Device class: 3
Device first issue date 2009-07-16
Licence name: RAPID RESPONSE STREP A TEST

Device details
Device first issue date Device name Identifier first issue date Device identifier
2009-07-16 RAPID RESPONSE STREP A TEST DEVICE 2009-07-16 STR-15C25
2009-07-16 RAPID RESPONSE STREP A TEST STRIP 2009-07-16 STR-15S25

Licence No.: 80631

Type: Test Kit
Device class: 2
Device first issue date 2009-09-10
Licence name: RAPID RESPONSE H. PYLORI TEST CASSETTE (SERUM/PLASMA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2009-09-10 RAPID RESPONSE H. PYLORI TEST CASSETTE (SERUM/PLASMA) 2009-09-10 HPY-12C15

Licence No.: 80632

Type: Test Kit
Device class: 2
Device first issue date 2009-09-10
Licence name: RAPID RESPONSE H. PYLORI TEST (WHOLE BLOOD/SERUM/PLASMA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2009-09-10 RAPID RESPONSE H. PYLORI TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA) 2010-03-15 HPY-13C15
2009-09-10 RAPID RESPONSE H. PYLORI TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) 2009-09-10 HPY-13S50

Licence No.: 80656

Type: Test Kit
Device class: 2
Device first issue date 2009-09-15
Licence name: RAPID RESPONSE INFLUENZA A+B TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2009-09-15 RAPID RESPONSE INFLUENZA A+B TEST CASSETTE 2009-09-15 FLUAB-19C20

Licence No.: 80983

Type: Test Kit
Device class: 2
Device first issue date 2009-10-23
Licence name: RAPID RESPONSE URINALYSIS REAGENT STRIPS (MULTIPLE TESTING)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 10 PARA 2009-10-23 U10.1-1S100-02
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 11 PARA 2009-10-23 U11.1-1S100
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 2 PARA 2009-10-23 U2.1-1S100-02
2009-10-23 U2.2-1S100
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 3 PARA 2009-10-23 U3.1-1S100-02
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 4 PARA 2009-10-23 U4.1-1S100-02
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 5 PARA 2009-10-23 U5.1-1S100
2016-04-12 U5.3-1S100
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 6 PARA 2009-10-23 U6.1-1S100-02
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 7 PARA 2009-10-23 U7.1-1S100-02
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 8 PARA 2009-10-23 U8.1-1S100-02
2009-10-23 RAPID RESPONSE URINALYSIS REAGENT STRIPS, 9 PARA 2009-10-23 U9.1-1S100-02

Licence No.: 82089

Type: Test Kit
Device class: 3
Device first issue date 2010-02-22
Licence name: ACON URINALYSIS REAGENT STRIPS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (1 PARAMETER) 2010-02-22 U031-016
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (10 PARAMETERS) 2010-02-22 U031-106
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (11 PARAMETERS) 2010-02-22 U031-116
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (2 PARAMETERS) 2010-02-22 U031-026
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (3 PARAMETERS) 2010-02-22 U031-036
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (4 PARAMETERS) 2010-02-22 U031-046
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (5 PARAMETERS) 2010-02-22 U031-056
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (6 PARAMETERS) 2010-02-22 U031-066
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (7 PARAMETERS) 2010-02-22 U031-076
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (8 PARAMETERS) 2010-02-22 U031-086
2010-02-22 DISTINCT URINALYSIS REAGENT STRIPS (9 PARAMETERS) 2010-02-22 U031-096
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (1 PARAMETER) 2010-02-22 U031-015
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (10 PARAMETERS) 2010-02-22 U031-105
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (11 PARAMETERS) 2010-02-22 U031-115
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (2 PARAMETERS) 2010-02-22 U031-025
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (3 PARAMETERS) 2010-02-22 U031-035
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (4 PARAMETERS) 2010-02-22 U031-045
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (5 PARAMETERS) 2010-02-22 U031-055
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (6 PARAMETERS) 2010-02-22 U031-065
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (7 PARAMETERS) 2010-02-22 U031-075
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (8 PARAMETERS) 2010-02-22 U031-085
2010-02-22 INSIGHT URINALYSIS REAGENT STRIPS (9 PARAMETERS) 2010-02-22 U031-095
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (1 PARAMETER) 2010-02-22 U031-011
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (10 PARAMETERS) 2010-02-22 U031-101
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (11 PARAMETERS) 2010-02-22 U031-111
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (2 PARAMETERS) 2010-02-22 U031-021
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (3 PARAMETERS) 2010-02-22 U031-031
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (4 PARAMETERS) 2010-02-22 U031-041
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (5 PARAMETERS) 2010-02-22 U031-051
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (6 PARAMETERS) 2010-02-22 U031-061
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (7 PARAMETERS) 2010-02-22 U031-071
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (8 PARAMETERS) 2010-02-22 U031-081
2010-02-22 MISSION URINALYSIS REAGENT STRIPS (9 PARAMETERS) 2010-02-22 U031-091

Licence No.: 82090

Type: Device Family
Device class: 3
Device first issue date 2010-02-22
Licence name: U120 URINE ANALYZERS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-02-22 DISTINCT U120 URINE ANALYZER 2010-02-22 U111-106
2010-02-22 DISTINCT U120 URINE ANALYZER WITH BARCODE READER 2010-02-22 U111-116
2010-02-22 INSIGHT U120 URINE ANALYZER WITH BARCODE READER 2010-02-22 U111-115
2010-02-22 VERIFY U120 URINE ANALYZER 2010-02-22 U111-102
2010-02-22 VERIFY U120 URINE ANALYZER WITH BARCODE READER 2010-02-22 U111-112
2010-10-06 INSIGHT U120 URINE ANALYZER 2010-10-06 U111-105
2020-02-17 RAPID RESPONSE U120S URINE ANALYZER WITH BARCODE READER 2020-02-17 UA-U121S
2020-03-06 RAPID RESPONSE U120S URINE ANALYZER 2020-03-06 UA-U120S

Licence No.: 82092

Type: Device Family
Device class: 3
Device first issue date 2010-02-22
Licence name: U500 URINE ANALYZER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-02-22 INSIGHT U500 URINE ANALYZER 2010-02-22 U211-105
2010-02-22 INSIGHT U500 URINE ANALYZER WITH BARCODE READER 2010-02-22 U211-115
2010-02-22 MISSION U500 URINE ANALYZER 2010-02-22 U211-101
2010-02-22 MISSION U500 URINE ANALYZER WITH BARCODE READER 2010-02-22 U211-111

Licence No.: 82681

Type: Test Kit
Device class: 2
Device first issue date 2010-04-26
Licence name: RAPID RESPONSE CREA-CHECK URINE ADULTERATION CREATININE TEST STRIPS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-04-26 RAPID RESPONSE CREA-CHECK URINE ADULTERATION CREATININE TEST STRIPS 2010-04-26 ADU-CRE1S25

Licence No.: 82738

Type: Test Kit
Device class: 3
Device first issue date 2010-05-04
Licence name: RAPID RESPONSE URINALYSIS REAGENT STRIPS (MULTIPLE TESTING)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-05-04 URINALYSIS REAGENT STRIPS 1 PARA (KET) 2010-05-04 U-KET-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 10 PARAMETERS 2010-05-04 U10.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 11 PARAMETERS 2010-05-04 U11.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 2 PARAMETERS 2010-05-04 U2.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 3 PARAMETERS 2010-05-04 U3.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 4 PARAMETERS 2010-05-04 U4.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 5 PARAMETERS 2010-05-04 U5.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 6 PARAMETERS 2010-05-04 U6.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 7 PARAMETERS 2010-05-04 U7.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 8 PARAMETERS 2010-05-04 U8.1-1S100
2010-05-04 URINALYSIS REAGENT STRIPS 9 PARAMETERS 2010-05-04 U9.1-1S100

Licence No.: 82862

Type: Device Family
Device class: 3
Device first issue date 2010-05-20
Licence name: RAPID RESPONSE U500 URINE ANALYZER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-05-20 RAPID RESPONSE U500 URINE ANALYZER 2010-05-20 UA-U500
2010-05-20 RAPID RESPONSE U500 URINE ANALYZER WITH BARCODE READER 2010-05-20 UA-U501

Licence No.: 82863

Type: Device Family
Device class: 3
Device first issue date 2010-05-20
Licence name: RAPID RESPONSE U120 URINE ANALYZER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-05-20 RAPID RESPONSE U120 URINE ANALYZER 2010-05-20 UA-U120
2010-05-20 RAPID RESPONSE U120 URINE ANALYZER WITH BARCODE READER 2010-05-20 UA-U121

Licence No.: 83047

Type: Test Kit
Device class: 2
Device first issue date 2010-06-10
Licence name: RAPID RESPONSE ROTAVIRUS AND ADENOVIRUS COMBO (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-06-10 RAPID RESPONSE ROTAVIRUS AND ADENOVIRUS COMBO TEST KIT (FECES) 2010-06-10 RAC-9C20

Licence No.: 83048

Type: Test Kit
Device class: 2
Device first issue date 2010-06-10
Licence name: RAPID RESPONSE ADENOVIRUS TEST KIT (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-06-10 RAPID RESPONSE ADENOVIRUS TEST KIT (FECES) 2010-06-10 AD-9C25

Licence No.: 83049

Type: Test Kit
Device class: 2
Device first issue date 2010-06-10
Licence name: RAPID RESPONSE ROTAVIRUS TEST KIT (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-06-10 RAPID RESPONSE ROTAVIRUS TEST KIT (FECES) 2010-06-10 ROT-9C20

Licence No.: 83215

Type: Device Family
Device class: 3
Device first issue date 2010-06-30
Licence name: UTI URINARY TRACT INFECTION TEST STRIPS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2010-06-30 INSIGHT UTI URINARY TRACT INFECTION TEST STRIPS 2010-06-30 U031-025
2010-06-30 MISSION UTI URINARY TRACT INFECTION TEST STRIPS 2010-06-30 U031-021

Licence No.: 84896

Type: Single Device
Device class: 2
Device first issue date 2011-01-14
Licence name: RAPID RESPONSE MICROALBUMIN CREATININE TEST STRIPS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2011-01-14 RAPID RESPONSE MICROALBUMIN CREATININE TEST STRIPS 2011-01-14 ALCR-1S100
2011-01-14 ALCR-1S25
2011-01-14 ALCR-1S50

Licence No.: 84925

Type: Device Family
Device class: 2
Device first issue date 2011-01-20
Licence name: URINE CONTROL

Device details
Device first issue date Device name Identifier first issue date Device identifier
2011-01-20 INSIGHT URINE CONTROL, DRY STRIP 2011-01-20 U021-045
2011-01-20 U021-055
2011-01-20 U021-065
2011-01-20 INSIGHT URINE CONTROL, LIQUID 2011-01-20 U021-015
2011-01-20 U021-025
2011-01-20 U021-035
2011-01-20 INSIGHT URINE CONTROL, LIQUID DIPTUBE 2011-01-20 U021-075
2011-01-20 U021-085
2011-01-20 U021-095
2011-01-20 MISSION URINE CONTROL, DRY STRIP 2011-01-20 U021-041
2011-01-20 U021-051
2011-01-20 U021-061
2011-01-20 MISSION URINE CONTROL, LIQUID 2011-01-20 U021-011
2011-01-20 U021-021
2011-01-20 U021-031
2011-01-20 MISSION URINE CONTROL, LIQUID DIPTUBE 2011-01-20 U021-071
2011-01-20 U021-081
2011-01-20 U021-091

Licence No.: 86166

Type: Test Kit
Device class: 2
Device first issue date 2011-05-20
Licence name: RAPID RESPONSE 1-STEP H. PYLORI ANTIGEN TEST (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2011-05-20 RAPID RESPONSE 1-STEP H. PYLORI ANTIGEN TEST (FECES) 2011-05-20 HPY-9C20

Licence No.: 86860

Type: Test Kit
Device class: 3
Device first issue date 2011-08-08
Licence name: RAPID RESPONSE 1-STEP DOA TEST

Device details
Device first issue date Device name Identifier first issue date Device identifier
2011-08-08 RAPID RESPONSE 1-STEP DOA CUP 2011-08-08 D1W-11
2012-01-25 RAPID RESPONSE 1-STEP DOA PANEL 2012-01-25 D2W-11
2012-01-25 RAPID RESPONSE 1-STEP DOA TEST 2012-01-25 D1W-11

Licence No.: 90406

Type: System
Device class: 3
Device first issue date 2012-12-28
Licence name: MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM

Device details
Device first issue date Device name Identifier first issue date Device identifier
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - CAPILLARY TRANSFER TUBES 2012-12-28 C121-3081
2012-12-28 C121-30811
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - CONTROL STRIPS 2012-12-28 C122-3011
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - ENTIRE SYSTEM 2012-12-28 C112-3011
2012-12-28 C112-3021
2013-11-20 C112-3031
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - LANCETS 2012-12-28 C121-3041
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - LANCING DEVICE 2012-12-28 C121-3051
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - METER 2012-12-28 C112-3011
2013-11-20 C112-3031
2012-12-28 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - TEST STRIPS 2012-12-28 C132-3011
2013-11-20 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - CONTROL DEVICE 2013-11-20 C122-3021
2013-11-20 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - CONTROL SOLUTION 2013-11-20 C121-3091
2013-11-20 MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM - TEST DEVICE 2013-11-20 C132-3021

Licence No.: 90746

Type: Device Family
Device class: 2
Device first issue date 2013-02-25
Licence name: RAPID RESPONSE URINE CONTROLS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2013-02-25 RAPID RESPONSE DRY STRIP URINE CONTROLS 2013-02-25 ADUCT-1S1
2013-02-25 ADUCT1-1S1
2013-02-25 ADUCT2-1S1
2013-02-25 RAPID RESPONSE LIQUID DIPTUBE URINE CONTROLS 2013-02-25 AUCT-1V1
2013-02-25 AUCT1-1V1
2013-02-25 AUCT2-1V1

Licence No.: 91337

Type: Test Kit
Device class: 3
Device first issue date 2013-05-15
Licence name: RAPID RESPONSE URINARY TRACT INFECTION TEST STRIPS

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-09-27 RAPID RESPONSE URINARY TRACT INFECTION TEST STRIPS 2023-09-27 UTI-1S1

Licence No.: 91686

Type: Test Kit
Device class: 2
Device first issue date 2013-07-16
Licence name: RAPID RESPONSE FECAL IMMUNOCHEMICAL TEST (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2013-07-16 RAPID RESPONSE FECAL IMMUNOCHEMICAL TEST 2013-07-16 FOB-9C36

Licence No.: 93362

Type: Test Kit
Device class: 2
Device first issue date 2014-06-04
Licence name: RAPID RESPONSE DRUGS OF ABUSE TESTS (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2014-06-04 RAPID RESPONSE 6-MONOACETY1MORPHINE TEST CASSETTE 2014-06-04 MAM-1C1-07
2014-06-04 RAPID RESPONSE 6-MONOACETYLMORPHINE TEST STRIP 2014-06-04 MAM-1S1-07
2014-06-04 RAPID RESPONSE ACETAMINOPHEN TEST CASSETTE 2014-06-04 ACE-1C1-07
2014-06-04 AMP-1C1-07
2014-06-04 AMP-1C2-07
2014-06-04 AMP-1C3-07
2014-06-04 RAPID RESPONSE ACETAMINOPHEN TEST STRIP 2014-06-04 ACE-1S1-07
2014-06-04 AMP-1S1-07
2014-06-04 AMP-1S2-07
2014-06-04 AMP-1S3-07
2014-06-04 RAPID RESPONSE BARBITURATES TEST CASSETTE 2014-06-04 BAR-1C1-07
2014-06-04 RAPID RESPONSE BARBITURATES TEST STRIP 2014-06-04 BAR-1S1-07
2014-06-04 RAPID RESPONSE BENZODIAZEPINES TEST CASSETTE 2014-06-04 BZO-1C1-07
2014-06-04 BZO-1C2-07
2014-06-04 BZO-1C3-07
2014-07-22 BZO-1C4-07
2014-06-04 RAPID RESPONSE BENZODIAZEPINES TEST STRIP 2014-06-04 BZO-1S1-07
2014-06-04 BZO-1S2-07
2014-06-04 BZO-1S3-07
2014-07-22 BZO-1S4-07
2014-06-04 RAPID RESPONSE BUPRENORPHINE TEST CASSETTE 2014-06-04 BUP-1C1-07
2014-06-04 BUP-1C2-07
2014-06-04 RAPID RESPONSE BUPRENORPHINE TEST STRIP 2014-06-04 BUP-1S1-07
2014-06-04 BUP-1S2-07
2014-06-04 RAPID RESPONSE COCAINE TEST CASSETTE 2014-06-04 COC-1C1-07
2014-06-04 COC-1C2-07
2014-06-04 COC-1C4-07
2014-07-22 COC-1C3-07
2014-06-04 RAPID RESPONSE COCAINE TEST STRIP 2014-06-04 COC-1S1-07
2014-06-04 COC-1S2-07
2014-06-04 COC-1S4-07
2014-07-22 COC-1S3-07
2014-06-04 RAPID RESPONSE COTININE TEST CASSETTE 2014-06-04 COT-1C1-07
2014-06-04 COT-1C2-07
2014-06-04 COT-1C3-07
2014-06-04 RAPID RESPONSE COTININE TEST STRIP 2014-06-04 COT-1S1-07
2014-06-04 COT-1S2-07
2014-06-04 COT-1S3-07
2014-06-04 RAPID RESPONSE EDDP TEST CASSETTE 2014-06-04 EDDP-1C1-07
2014-06-04 EDDP-1C2-07
2014-06-04 RAPID RESPONSE EDDP TEST STRIP 2014-06-04 EDDP-1S1-07
2014-06-04 EDDP-1S2-07
2014-06-04 RAPID RESPONSE ETHYL GLUCURONIDE TEST CASSETTE 2014-06-04 ETG-1C1-07
2014-06-04 RAPID RESPONSE ETHYL GLUCURONIDE TEST STRIP 2014-06-04 ETG-1S1-07
2014-06-04 RAPID RESPONSE FENTANYL TEST CASSETTE 2014-06-04 FYL-1C1-07
2014-06-04 FYL-1C3-07
2014-06-04 RAPID RESPONSE FENTANYL TEST STRIP 2014-06-04 FYL-1S1-07
2014-06-04 FYL-1S3-07
2014-06-04 RAPID RESPONSE HYDROMORPHONE TEST CASSETTE 2014-06-04 HMO-1C1-07
2014-06-04 RAPID RESPONSE HYDROMORPHONE TEST STRIP 2014-06-04 HMO-1S1-07
2014-06-04 RAPID RESPONSE KETAMINE TEST CASSETTE 2014-06-04 KET-1C1-07
2014-06-04 RAPID RESPONSE KETAMINE TEST STRIP 2014-06-04 KET-1S1-07
2014-06-04 RAPID RESPONSE LYSERGIC ACID DIETHYLAMIDE TEST CASSETTE 2014-06-04 LSD-1C1-07
2014-06-04 RAPID RESPONSE LYSERGIC ACID DIETHYLAMIDE TEST STRIP 2014-06-04 LSD-1S1-07
2014-06-04 RAPID RESPONSE MARIJUANA TEST CASSETTE 2014-06-04 THC-1C1-07
2014-06-04 THC-1C2-07
2014-06-04 THC-1C3-07
2014-06-04 THC-1C4-07
2014-06-04 RAPID RESPONSE MARIJUANA TEST STRIP 2014-06-04 THC-1S1-07
2014-06-04 THC-1S2-07
2014-06-04 THC-1S3-07
2014-06-04 THC-1S4-07
2014-06-04 RAPID RESPONSE MDMA TEST CASSETTE 2014-06-04 MDM-1C1-07
2014-06-04 MDM-1C2-07
2014-06-04 RAPID RESPONSE MDMA TEST STRIP 2014-06-04 MDM-1S1-07
2014-06-04 MDM-1S2-07
2014-06-04 RAPID RESPONSE METHADONE TEST CASSETTE 2014-06-04 MTD-1C1-07
2014-06-04 RAPID RESPONSE METHADONE TEST STRIP 2014-06-04 MTD-1S1-07
2014-06-04 RAPID RESPONSE METHAMPHETAMINE TEST CASSETTE 2014-06-04 MET-1C1-07
2014-06-04 MET-1C2-07
2014-06-04 MET-1C3-07
2014-06-04 RAPID RESPONSE METHAMPHETAMINE TEST STRIP 2014-06-04 MET-1S1-07
2014-06-04 MET-1S2-07
2014-06-04 MET-1S3-07
2014-06-04 RAPID RESPONSE METHAQUALONE TEST CASSETTE 2014-06-04 MQL-1C1-07
2014-06-04 RAPID RESPONSE METHAQUALONE TEST STRIP 2014-06-04 MQL-1S1-07
2014-06-04 RAPID RESPONSE METHYPHENIDATE TEST CASSETTE 2014-06-04 MPD-1C1-07
2014-06-04 RAPID RESPONSE METHYPHENIDATE TEST STRIP 2014-06-04 MPD-1S1-07
2014-06-04 RAPID RESPONSE MORPHINE TEST CASSETTE 2014-06-04 MOP-1C1-07
2014-06-04 MOP-1C2-07
2014-06-04 MOP-1C3-07
2014-06-04 RAPID RESPONSE MORPHINE TEST STRIP 2014-06-04 MOP-1S1-07
2014-06-04 MOP-1S2-07
2014-06-04 MOP-1S3-07
2014-06-04 RAPID RESPONSE MULTI-DRUG INTEGRATED SPLIT SPEC. CUP W/WO ADULTERATION 2014-06-04 D-1G-07
2014-06-04 RAPID RESPONSE MULTI-DRUG ONE STEP CUP W/WO ADULTERATION 2014-06-04 D-1U-07
2014-12-03 D-1V-07
2014-06-04 RAPID RESPONSE MULTI-DRUG TEST CASSETTE W/WO ADULTERATION 2014-06-04 D-1E-07
2014-06-04 RAPID RESPONSE MULTI-DRUG TEST PANEL W/WO ADULTERATION 2014-06-04 D-1P-07
2014-06-04 RAPID RESPONSE OPIATE TEST CASSETTE 2014-06-04 OPI-1C1-07
2014-06-04 OPI-1C2-07
2014-06-04 RAPID RESPONSE OPIATE TEST STRIP 2014-06-04 OPI-1S1-07
2014-06-04 OPI-1S2-07
2014-06-04 RAPID RESPONSE OXYCODONE TEST CASSETTE 2014-06-04 OXY-1C1-07
2014-06-04 OXY-1C2-07
2014-06-04 RAPID RESPONSE OXYCODONE TEST STRIP 2014-06-04 OXY-1S1-07
2014-06-04 OXY-1S2-07
2014-06-04 RAPID RESPONSE PHENCYCLIDINE TEST CASSETTE 2014-06-04 PCP-1C1-07
2014-06-04 RAPID RESPONSE PHENCYCLIDINE TEST STRIP 2014-06-04 PCP-1S1-07
2014-06-04 RAPID RESPONSE PROPOXYPHENE TEST CASSETTE 2014-06-04 PPX-1C1-07
2014-06-04 RAPID RESPONSE PROPOXYPHENE TEST STRIP 2014-06-04 PPX-1S1-07
2014-06-04 RAPID RESPONSE SYNTHETIC MARIJUANA TEST CASSETTE 2014-06-04 K2-1C1-07
2014-06-04 RAPID RESPONSE SYNTHETIC MARIJUANA TEST STRIP 2014-06-04 K2-1S1-07
2014-06-04 RAPID RESPONSE TRAMADOL TEST CASSETTE 2014-06-04 TRA-1C1-07
2014-06-04 TRA-1C2-07
2014-06-04 RAPID RESPONSE TRAMADOL TEST STRIP 2014-06-04 TRA-1S1-07
2014-06-04 TRA-1S2-07
2014-06-04 RAPID RESPONSE TRICYCLIC ANTIDEPRESSANTS TEST CASSETTE 2014-06-04 TCA-1C1-07
2014-06-04 RAPID RESPONSE TRICYCLIC ANTIDEPRESSANTS TEST STRIP 2014-06-04 TCA-1S1-07
2014-06-04 RAPID RESPONSE ZOLPIDEM TEST CASSETTE 2014-06-04 ZOL-1C1-07
2014-06-04 RAPID RESPONSE ZOLPIDEM TEST STRIP 2014-06-04 ZOL-1S1-07

Licence No.: 94773

Type: Single Device
Device class: 2
Device first issue date 2015-02-25
Licence name: RAPID RESPONSE NOROVIRUS TEST CASSETTE (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-02-25 RAPID RESPONSE NOROVIRUS TEST CASSETTE (FECES) 2015-02-25 NOR-9C

Licence No.: 95116

Type: Test Kit
Device class: 2
Device first issue date 2015-05-07
Licence name: RAPID RESPONSE URINE ADULTERATION TEST STRIP

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-05-07 RAPID RESPONSE URINE ADULTERATION TEST STRIP 2015-05-07 URA-1S65
2015-05-07 URA-1S65-100

Licence No.: 95417

Type: Device Family
Device class: 2
Device first issue date 2015-07-07
Licence name: RAPID RESPONSE PROCALCITONIN (PCT) TEST CASSETTE (SERUM/PLASMA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-07-07 RAPID RESPONSE PROCALCITONIN (PCT) TEST CASSETTE (SERUM/PLASMA) 2015-07-07 PCT-12C
2024-06-14 PCT-12C40

Licence No.: 96154

Type: Device Family
Device class: 2
Device first issue date 2015-11-25
Licence name: RAPID RESPONSE DRUGS OF ABUSE TESTS (URINE) PANEL

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-11-25 RAPID RESPONSE MULTI-DRUG TEST PANEL W/WO ADULTERATION 2015-11-25 D-10.XXP-13
2015-11-25 D-11.XXP-13
2015-11-25 D-12.XXP-13
2015-11-25 D-2.XXP-13
2015-11-25 D-3.XXP-13
2015-11-25 D-4.XXP-13
2015-11-25 D-5.XXP-13
2015-11-25 D-6.XXP-13
2015-11-25 D-7.XXP-13
2015-11-25 D-8.XXP-13
2015-11-25 D-9.XXP-13
2015-11-25 RAPID RESPONSE SINGLE-DRUG TEST PANEL W/WO ADULTERATION 2015-11-25 D-1.XXP.13

Licence No.: 96236

Type: Device Family
Device class: 2
Device first issue date 2015-12-14
Licence name: RAPID RESPONSE DRUGS OF ABUSE TESTS (URINE) CUP

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-12-14 RAPID RESPONSE MULTI-DRUG TEST CUP W/WO ADULTERATION 2015-12-14 D-10.XXG-13
2015-12-14 D-10.XXU-13
2015-12-14 D-11.XXG-13
2015-12-14 D-11.XXU-13
2015-12-14 D-12.XXG-13
2015-12-14 D-12.XXU-13
2015-12-14 D-2.XXG-13
2015-12-14 D-2.XXU-13
2015-12-14 D-3.XXG-13
2015-12-14 D-3.XXU-13
2015-12-14 D-4.XXG-13
2015-12-14 D-4.XXU-13
2015-12-14 D-5.XXG-13
2015-12-14 D-5.XXU-13
2015-12-14 D-6.XXG-13
2015-12-14 D-6.XXU-13
2015-12-14 D-7.XXG-13
2015-12-14 D-7.XXU-13
2015-12-14 D-8.XXG-13
2015-12-14 D-8.XXU-13
2015-12-14 D-9.XXG-13
2015-12-14 D-9.XXU-13

Licence No.: 96237

Type: Single Device
Device class: 2
Device first issue date 2015-12-23
Licence name: RAPID RESPONSE THYROID STIMULATING HORMONE (TSH) TEST CASSETTE (WHOLE BLOOD)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2015-12-23 RAPID RESPONSE THYROID STIMULATING HORMONE (TSH) TEST CASSETTE (WHOLE BLOOD) 2015-12-23 TSH-13C20

Licence No.: 96698

Type: System
Device class: 3
Device first issue date 2016-03-18
Licence name: RAPID RESPONSE GLUCO-MD BLOOD GLUCOSE MONITORING SYSTEM

Device details
Device first issue date Device name Identifier first issue date Device identifier
2016-03-18 RAPID RESPONSE GLUCO-MD-BLOOD GLUCOSE METER-ONLY 2016-03-18 BG-11M
2016-03-18 RAPID RESPONSE GLUCO-MD-BLOOD GLUCOSE TEST STRIPS 2016-03-18 BG-11TS
2016-03-18 RAPID RESPONSE GLUCO-MD-GLUCOSE CONTROL SOLUTION 2016-03-18 BG-11CS
2016-03-18 RAPID RESPONSE GLUCO-MD-LANCETS 2016-03-18 BG-11L
2016-03-18 RAPID RESPONSE GLUCO-MD-LANCING DEVICE 2016-03-18 BG-11LD

Licence No.: 97357

Type: Single Device
Device class: 2
Device first issue date 2016-07-22
Licence name: RAPID RESPONSE DIGITAL PREGNANCY TEST

Device details
Device first issue date Device name Identifier first issue date Device identifier
2016-07-22 RAPID RESPONSE DIGITAL PREGNANCY TEST 2016-07-22 HCG-1DM

Licence No.: 97557

Type: System
Device class: 2
Device first issue date 2016-08-18
Licence name: RAPID RESPONSE DIGITAL OVULATION TEST METER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2016-08-18 RAPID RESPONSE DIGITAL OVULATION TEST METER 2016-08-18 LH-1DM
2016-08-18 RAPID RESPONSE DIGITAL OVULATION TEST STRIP 2016-08-18 LH-1DTS

Licence No.: 100304

Type: Test Kit
Device class: 3
Device first issue date 2017-12-27
Licence name: RAPID RESPONSE DRUGS OF ABUSE TESTING PANEL (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2017-12-27 RAPID RESPONSE MULTI-DRUG TEST PANEL (URINE) 2020-10-13 D-1P1-07
2020-10-13 D-1P10-07
2020-10-13 D-1P11-07
2020-10-13 D-1P12-07
2020-10-13 D-1P13-07
2020-10-13 D-1P14-07
2020-10-13 D-1P15-07
2020-10-13 D-1P16-07
2020-10-13 D-1P2-07
2020-10-13 D-1P3-07
2020-10-13 D-1P4-07
2020-10-13 D-1P5-07
2020-10-13 D-1P6-07
2020-10-13 D-1P7-07
2020-10-13 D-1P8-07
2020-10-13 D-1P9-07
2020-10-13 RAPID RESPONSE MULTI-DRUG TEST STRIP 2020-10-13 6-MAM10
2020-10-13 ALC
2020-10-13 AMP1000
2020-10-13 AMP500
2020-10-13 BAR300
2020-10-13 BUP10
2020-10-13 BZO300
2020-10-13 COC150
2020-10-13 COC300
2020-10-13 COT200
2020-10-13 EDDP100
2020-10-13 ETG500
2020-10-13 FYL10
2020-10-13 HMO300
2020-10-13 K2 50
2020-10-13 KET1000
2020-10-13 LSD10
2020-10-13 MDMA500
2020-10-13 MET1000
2020-10-13 MET500
2020-10-13 MOP300
2020-10-13 MTD300
2020-10-13 NIT/GLUT/CRE
2020-10-13 OPI2000
2020-10-13 OXI/SG/PH
2020-10-13 OXY100
2020-10-13 PCP25
2020-10-13 PGB1000
2020-10-13 PPX300
2020-10-13 THC50
2020-10-13 TML100

Licence No.: 100842

Type: Device Family
Device class: 2
Device first issue date 2018-04-12
Licence name: RAPID RESPONSE SINGLE DRUG SALIVA TEST CUP

Device details
Device first issue date Device name Identifier first issue date Device identifier
2018-04-12 RAPID RESPONSE SINGLE DRUG SALIVA TEST CUP 2018-04-12 6MAM-2T
2018-04-12 ALC-2T
2018-04-12 AMP-2T
2018-04-12 BAR-2T
2018-04-12 BUP-2T
2018-04-12 BZO-2T
2018-04-12 COC-2T
2018-04-12 COT-2T
2018-04-12 EDDP-2T
2018-04-12 FYL-2T
2018-04-12 K2-2T
2018-04-12 KET-2T
2018-04-12 LSD-2T
2018-04-12 MDMA-2T
2018-04-12 MDPV-2T
2018-04-12 MET-2T
2018-04-12 MOP-2T
2018-04-12 MQL-2T
2018-04-12 MTD-2T
2018-04-12 OPI-2T
2018-04-12 OXY-2T
2018-04-12 PCP-2T
2018-04-12 PPX-2T
2018-04-12 TCA-2T
2018-04-12 THC-2T
2018-04-12 TRA-2T

Licence No.: 100914

Type: System
Device class: 2
Device first issue date 2018-04-24
Licence name: RAPID RESPONSE MULTI DRUG SALIVA TEST CUP

Device details
Device first issue date Device name Identifier first issue date Device identifier
2018-04-24 RAPID RESPONSE MULTI DRUG SALIVA TEST CUP 2018-04-24 DX-2T1
2018-04-24 RAPID RESPONSE MULTI DRUG SALIVA TEST CUP (STRIPS) 2018-04-24 6MAM-2TS
2018-04-24 ALC-2TS
2018-04-24 AMP-2TS
2018-04-24 BAR-2TS
2018-04-24 BUP-2TS
2018-04-24 BZ0-2TS
2018-04-24 COC-2TS
2018-04-24 COT-2TS
2018-04-24 EDDP-2TS
2018-04-24 FYL-2TS
2018-04-24 K2-2TS
2018-04-24 KET-2TS
2018-04-24 LSD-2TS
2018-04-24 MDMA-2TS
2018-04-24 MDPV-2TS
2018-04-24 MET-2TS
2018-04-24 MOP-2TS
2018-04-24 MQL-2TS
2018-04-24 MTD-2TS
2018-04-24 OPI-2TS
2018-04-24 OXY-2TS
2018-04-24 PCP-2TS
2018-04-24 PPX-2TS
2018-04-24 TCA-2TS
2018-04-24 THC-2TS
2018-04-24 TRA-2TS

Licence No.: 100921

Type: Device Family
Device class: 2
Device first issue date 2018-04-25
Licence name: RAPID RESPONSE SAFETY LANCET

Device details
Device first issue date Device name Identifier first issue date Device identifier
2018-04-25 RAPID RESPONSE SAFETY LANCET 2018-04-25 SLAN-21G-100
2018-04-25 SLAN-21G-25
2018-04-25 SLAN-28G-100
2018-04-25 SLAN-28G-25
2020-07-13 SLAN-23G-100
2020-07-13 SLAN-23G-25
2020-07-13 SLAN-30G-100
2020-07-13 SLAN-30G-25

Licence No.: 102569

Type: System
Device class: 3
Device first issue date 2019-03-14
Licence name: RAPID RESPONSE HEMOGLOBIN A1C ANALYZER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2019-03-14 RAPID RESPONSE HEMOGLOBIN A1C ANALYZER 2019-03-14 BA-A1C
2019-03-14 RAPID RESPONSE HEMOGLOBIN A1C CONTROL SOLUTIONS 2019-03-14 CTR-A1C
2019-03-14 RAPID RESPONSE HEMOGLOBIN A1C REAGENT CARTRIDGE 2019-03-14 RC-A1C

Licence No.: 103058

Type: Device Family
Device class: 3
Device first issue date 2019-06-26
Licence name: RAPID RESPONSE DRUG SCREENING PANEL (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2019-06-26 RAPID RESPONSE DRUG SCREENING PANEL (URINE) 2019-06-26 6-MAM10
2019-06-26 7-ACL100
2019-06-26 7-ACL200
2019-06-26 7-ACL300
2019-06-26 A-PVP1000
2019-06-26 A-PVP300
2019-06-26 A-PVP500
2019-06-26 ABP10
2019-06-26 ACE5000
2019-06-26 ALP100
2019-06-26 AMP1000
2019-06-26 AMP300
2019-06-26 AMP500
2019-06-26 BAR200
2019-06-26 BAR300
2019-06-26 BUP10
2019-06-26 BUP5
2019-06-26 BZ0200
2019-06-26 BZO100
2019-06-26 BZO300
2019-06-26 BZO500
2019-06-26 CAF1000
2019-06-26 CAT150
2019-06-26 CFYL500
2019-06-26 CLO150
2019-06-26 CLO400
2019-06-26 COC100
2019-06-26 COC150
2019-06-26 COC200
2019-06-26 COC300
2019-06-26 COT100
2019-06-26 COT200
2019-06-26 DIA200
2019-06-26 DIA300
2019-06-26 EDDP100
2019-06-26 EDDP300
2019-06-26 ETG1000
2019-06-26 ETG500
2019-06-26 FYL10
2019-06-26 FYL20
2019-06-26 K2 25
2019-06-26 K2 30
2019-06-26 K2 50
2019-06-26 KET100
2019-06-26 KET1000
2019-06-26 KET300
2019-06-26 KET500
2019-06-26 LSD20
2019-06-26 LSD50
2019-06-26 MCAT500
2019-06-26 MDA500
2019-06-26 MDMA1000
2019-06-26 MDMA300
2019-06-26 MDMA500
2019-06-26 MDPV1000
2019-06-26 MET1000
2019-06-26 MET300
2019-06-26 MET500
2019-06-26 MOP100
2019-06-26 MOP200
2019-06-26 MOP300
2019-06-26 MPD300
2019-06-26 MQL300
2019-06-26 MTD200
2019-06-26 MTD300
2019-06-26 OPI2000
2019-06-26 OXY100
2019-06-26 PCP25
2019-06-26 PGB50000
2019-06-26 PPX300
2019-06-26 TCA1000
2019-06-26 THC150
2019-06-26 THC200
2019-06-26 THC25
2019-06-26 THC30
2019-06-26 THC300
2019-06-26 THC50
2019-06-26 TML100
2019-06-26 TML200
2019-06-26 TML300
2019-06-26 TRO350
2019-06-26 ZOL50
2019-06-26 ZOP50

Licence No.: 103209

Type: Test Kit
Device class: 2
Device first issue date 2019-07-16
Licence name: RAPID RESPONSE ENTAMOEBA HISTOLYTICA TEST CASSETTE (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2019-07-16 RAPID RESPONSE ENTAMOEBA HISTOLYTICA TEST CASSETTE (FECES) 2019-07-16 ENT-9C10

Licence No.: 103549

Type: Single Device
Device class: 2
Device first issue date 2019-09-05
Licence name: RAPID RESPONSE LATERAL FLOW READER

Device details
Device first issue date Device name Identifier first issue date Device identifier
2019-09-05 RAPID RESPONSE LATERAL FLOW READER 2019-09-05 LFA-1.0

Licence No.: 104985

Type: Test Kit
Device class: 2
Device first issue date 2020-07-31
Licence name: RAPID RESPONSE MONONUCLEOSIS TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2020-07-31 RAPID RESPONSE MONONUCLEOSIS TEST CASSETTE 2020-07-31 MON-13C15

Licence No.: 105080

Type: Test Kit
Device class: 3
Device first issue date 2020-08-26
Licence name: RAPID RESPONSE MULTI-DRUG TEST CUP (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2020-08-26 RAPID RESPONSE ADULTERATION STRIPS 2020-08-26 NIT/GLUT/CRE
2020-08-26 OXI/SG/PH
2020-08-26 RAPID RESPONSE MULTI-DRUG TEST CUP (URINE) 2020-08-26 D-1V1-07
2020-08-26 D-1V10-07
2020-08-26 D-1V11-07
2020-08-26 D-1V12-07
2020-08-26 D-1V13-07
2020-08-26 D-1V2-07
2020-08-26 D-1V3-07
2020-08-26 D-1V4-07
2020-08-26 D-1V5-07
2020-08-26 D-1V6-07
2020-08-26 D-1V7-07
2020-08-26 D-1V8-07
2020-08-26 D-1V9-07
2020-08-26 RAPID RESPONSE MULTI-DRUG TEST CUP (URINE) WITH ADULTERATION STRIPS 2020-08-26 D-1V10A-07
2020-08-26 D-1V10AB-07
2020-08-26 D-1V10B-07
2020-08-26 D-1V11A-07
2020-08-26 D-1V11AB-07
2020-08-26 D-1V11B-07
2020-08-26 D-1V12A-07
2020-08-26 D-1V12AB-07
2020-08-26 D-1V12B-07
2020-08-26 D-1V13A-07
2020-08-26 D-1V13AB-07
2020-08-26 D-1V13B-07
2020-08-26 D-1V1A-07
2020-08-26 D-1V1AB-07
2020-08-26 D-1V1B-07
2020-08-26 D-1V2A-07
2020-08-26 D-1V2AB-07
2020-08-26 D-1V2B-07
2020-08-26 D-1V3A-07
2020-08-26 D-1V3AB-07
2020-08-26 D-1V3B-07
2020-08-26 D-1V4A-07
2020-08-26 D-1V4AB-07
2020-08-26 D-1V4B-07
2020-08-26 D-1V5A-07
2020-08-26 D-1V5AB-07
2020-08-26 D-1V5B-07
2020-08-26 D-1V6A-07
2020-08-26 D-1V6AB-07
2020-08-26 D-1V6B-07
2020-08-26 D-1V7A-07
2020-08-26 D-1V7AB-07
2020-08-26 D-1V7B-07
2020-08-26 D-1V8A-07
2020-08-26 D-1V8AB-07
2020-08-26 D-1V8B-07
2020-08-26 D-1V9A-07
2020-08-26 D-1V9AB-07
2020-08-26 D-1V9B-07
2020-08-26 RAPID RESPONSE TEST STRIPS 2020-08-26 6-MAM10
2020-08-26 ALC
2020-08-26 AMP1000
2020-08-26 AMP500
2020-08-26 BAR300
2020-08-26 BUP10
2020-08-26 BZO300
2020-08-26 COC150
2020-08-26 COC300
2020-08-26 COT200
2020-08-26 EDDP100
2020-08-26 ETG500
2020-08-26 FYL10
2020-08-26 HMO300
2020-08-26 K2 50
2020-08-26 KET1000
2020-08-26 LSD10
2020-08-26 MDMA500
2020-08-26 MET1000
2020-08-26 MET500
2020-08-26 MOR300
2020-08-26 MTD300
2020-08-26 OPI2000
2020-08-26 OXY100
2020-08-26 PCP25
2020-08-26 PGB1000
2020-08-26 PPX300
2020-08-26 THC50
2020-08-26 TML100

Licence No.: 106045

Type: Test Kit
Device class: 2
Device first issue date 2021-04-16
Licence name: RAPID RESPONSE FILARIASIS IGG/IGM TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2021-04-16 RAPID RESPONSE FILARIASIS IGG/IGM TEST CASSETTE 2021-04-16 FIL-13C40

Licence No.: 106402

Type: Test Kit
Device class: 2
Device first issue date 2021-07-16
Licence name: RAPID RESPONSE DRUG TEST CASSETTE (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2021-07-16 RAPID RESPONSE MULTI-DRUG TEST CASSETTE 2021-07-16 D-1E-07
2021-07-16 RAPID RESPONSE SINGLE DRUG TEST CASSETTE 2021-07-16 6-MAM10
2021-07-16 7-ACL200
2021-07-16 7-ACL300
2021-07-16 ACE5000
2021-07-16 ALP100
2021-07-16 AMP1000
2021-07-16 AMP300
2021-07-16 AMP500
2021-07-16 APVP500
2021-07-16 BAR100
2021-07-16 BAR200
2021-07-16 BAR300
2021-07-16 BUP10
2021-07-16 BUP5
2021-07-16 BZO100
2021-07-16 BZO200
2021-07-16 BZO300
2021-07-16 BZO500
2021-07-16 CAF8000
2021-07-16 CAT100
2021-07-16 CFYL500
2021-07-16 CLO150
2021-07-16 COC100
2021-07-16 COC150
2021-07-16 COC200
2021-07-16 COC300
2021-07-16 COT100
2021-07-16 COT1000
2021-07-16 COT200
2021-07-16 COT300
2021-07-16 COT600
2021-07-16 DIA100
2021-07-16 EDDP100
2021-07-16 EDDP300
2021-07-16 ETG1000
2021-07-16 ETG300
2021-07-16 ETG500
2021-07-16 FYL10
2021-07-16 FYL200
2021-07-16 GAB2000
2021-07-16 HMO1000
2021-07-16 HMO250
2021-07-16 HMO500
2021-07-16 K2 30
2021-07-16 K2 50
2021-07-16 K3 25
2021-07-16 K4 25
2021-07-16 KET1000
2021-07-16 KET300
2021-07-16 KET500
2021-07-16 KRA25
2021-07-16 LSD20
2021-07-16 LSD50
2021-07-16 MCAT500
2021-07-16 MDA500
2021-07-16 MDMA1000
2021-07-16 MDMA300
2021-07-16 MDMA500
2021-07-16 MDPHP500
2021-07-16 MDPV1000
2021-07-16 MDPV500
2021-07-16 MEP500
2021-07-16 MES500
2021-07-16 MET1000
2021-07-16 MET300
2021-07-16 MET500
2021-07-16 MOR100
2021-07-16 MOR200
2021-07-16 MOR300
2021-07-16 MPD150
2021-07-16 MPD300
2021-07-16 MQL300
2021-07-16 MTD200
2021-07-16 MTD300
2021-07-16 NFYL20
2021-07-16 OPI1000
2021-07-16 OPI2000
2021-07-16 OXY100
2021-07-16 OXY300
2021-07-16 PCP25
2021-07-16 PGB1000
2021-07-16 PGB500
2021-07-16 PPX300
2021-07-16 SOMA1000
2021-07-16 TAP1000
2021-07-16 TCA1000
2021-07-16 TCA300
2021-07-16 THC150
2021-07-16 THC200
2021-07-16 THC25
2021-07-16 THC300
2021-07-16 THC50
2021-07-16 THC500
2021-07-16 TLD300
2021-07-16 TML100
2021-07-16 TML300
2021-07-16 TPM350
2021-07-16 TZD200
2021-07-16 ZAL100
2021-07-16 ZOL25
2021-07-16 ZOL50
2021-07-16 ZOP50
2023-11-09 COC-1C3-100
2023-11-09 THC-1C13-100
2023-11-23 COC-1C3-40
2023-11-23 THC-1C13-40

Licence No.: 106892

Type: Device Family
Device class: 2
Device first issue date 2021-10-29
Licence name: RAPID RESPONSE MULTI-DRUG TEST CUP (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2021-10-29 RAPID RESPONSE MULTI-DRUG INTEGRATED SPLIT SPECIMEN CUP (URINE) 2021-10-29 6-MAM10
2021-10-29 ACE5000
2021-10-29 ALP100
2021-10-29 AMP1000
2021-10-29 AMP300
2021-10-29 AMP500
2021-10-29 APVP500
2021-10-29 BAR100
2021-10-29 BAR200
2021-10-29 BAR300
2021-10-29 BUP10
2021-10-29 BUP5
2021-10-29 BZO100
2021-10-29 BZO200
2021-10-29 BZO300
2021-10-29 BZO500
2021-10-29 CAF8000
2021-10-29 CFYL500
2021-10-29 CLO150
2021-10-29 COC100
2021-10-29 COC150
2021-10-29 COC200
2021-10-29 COC300
2021-10-29 COT100
2021-10-29 COT1000
2021-10-29 COT200
2021-10-29 COT300
2021-10-29 COT600
2021-10-29 D-1G1-107
2021-10-29 D-1G10-107
2021-10-29 D-1G11-107
2021-10-29 D-1G12-107
2021-10-29 D-1G13-107
2021-10-29 D-1G14-107
2021-10-29 D-1G2-107
2021-10-29 D-1G3-107
2021-10-29 D-1G4-107
2021-10-29 D-1G5-107
2021-10-29 D-1G6-107
2021-10-29 D-1G7-107
2021-10-29 D-1G8-107
2021-10-29 D-1G9-107
2021-10-29 DIA100
2021-10-29 EDDP100
2021-10-29 EDDP300
2021-10-29 ETG1000
2021-10-29 ETG300
2021-10-29 ETG500
2021-10-29 GAB2000
2021-10-29 GHB10000
2021-10-29 HMO1000
2021-10-29 HMO250
2021-10-29 HMO500
2021-10-29 K2-30
2021-10-29 K2-50
2021-10-29 K3-25
2021-10-29 K4-25
2021-10-29 KET1000
2021-10-29 KET300
2021-10-29 KET500
2021-10-29 KRA500
2021-10-29 LSD20
2021-10-29 LSD50
2021-10-29 MCAT500
2021-10-29 MDA500
2021-10-29 MDMA1000
2021-10-29 MDMA300
2021-10-29 MDMA500
2021-10-29 MDPHP500
2021-10-29 MDPV1000
2021-10-29 MDPV500
2021-10-29 MEP500
2021-10-29 MES500
2021-10-29 MET1000
2021-10-29 MET300
2021-10-29 MET500
2021-10-29 MOP100
2021-10-29 MOP200
2021-10-29 MOP300
2021-10-29 MPD150
2021-10-29 MPD300
2021-10-29 MQL300
2021-10-29 MTD200
2021-10-29 MTD300
2021-10-29 NFYL20
2021-10-29 OPI1000
2021-10-29 OPI2000
2021-10-29 OXY100
2021-10-29 OXY300
2021-10-29 PCP25
2021-10-29 PGB1000
2021-10-29 PGB500
2021-10-29 PPX300
2021-10-29 SOMA1000
2021-10-29 TAP1000
2021-10-29 TCA1000
2021-10-29 TCA300
2021-10-29 THC150
2021-10-29 THC200
2021-10-29 THC25
2021-10-29 THC300
2021-10-29 THC50
2021-10-29 THC500
2021-10-29 TRA100
2021-10-29 TRA300
2021-10-29 ZOL25
2021-10-29 ZOL50
2021-10-29 ZOP50
2023-08-21 FYL10
2023-08-21 FYL20
2021-10-29 RAPID RESPONSE MULTI-DRUG INTEGRATED SPLIT SPECIMEN CUP + ADULTERATION (URINE) 2021-10-29 6-MAM10
2021-10-29 ACE5000
2021-10-29 ALP100
2021-10-29 AMP1000
2021-10-29 AMP300
2021-10-29 AMP500
2021-10-29 APVP500
2021-10-29 BAR100
2021-10-29 BAR200
2021-10-29 BAR300
2021-10-29 BUP10
2021-10-29 BUP5
2021-10-29 BZO100
2021-10-29 BZO200
2021-10-29 BZO300
2021-10-29 BZO500
2021-10-29 CAF8000
2021-10-29 CFYL500
2021-10-29 CLO150
2021-10-29 COC100
2021-10-29 COC150
2021-10-29 COC200
2021-10-29 COC300
2021-10-29 COT100
2021-10-29 COT1000
2021-10-29 COT200
2021-10-29 COT300
2021-10-29 COT600
2021-10-29 D-1G10A-107
2021-10-29 D-1G11A-107
2021-10-29 D-1G12A-107
2021-10-29 D-1G13A-107
2021-10-29 D-1G14A-107
2021-10-29 D-1G1A-107
2021-10-29 D-1G2A-107
2021-10-29 D-1G3A-107
2021-10-29 D-1G4A-107
2021-10-29 D-1G5A-107
2021-10-29 D-1G6A-107
2021-10-29 D-1G7A-107
2021-10-29 D-1G8A-107
2021-10-29 D-1G9A-107
2021-10-29 DIA100
2021-10-29 EDDP100
2021-10-29 EDDP300
2021-10-29 ETG1000
2021-10-29 ETG300
2021-10-29 ETG500
2021-10-29 GAB2000
2021-10-29 GHB10000
2021-10-29 HMO1000
2021-10-29 HMO250
2021-10-29 HMO500
2021-10-29 K2-30
2021-10-29 K2-50
2021-10-29 K3-25
2021-10-29 K4-25
2021-10-29 KET1000
2021-10-29 KET300
2021-10-29 KET500
2021-10-29 KRA500
2021-10-29 LSD20
2021-10-29 LSD50
2021-10-29 MCAT500
2021-10-29 MDA500
2021-10-29 MDMA1000
2021-10-29 MDMA300
2021-10-29 MDMA500
2021-10-29 MDPHP500
2021-10-29 MDPV1000
2021-10-29 MDPV500
2021-10-29 MEP500
2021-10-29 MES500
2021-10-29 MET1000
2021-10-29 MET300
2021-10-29 MET500
2021-10-29 MOP100
2021-10-29 MOP200
2021-10-29 MOP300
2021-10-29 MPD150
2021-10-29 MPD300
2021-10-29 MQL300
2021-10-29 MTD200
2021-10-29 MTD300
2021-10-29 NFYL20
2021-10-29 OPI1000
2021-10-29 OPI2000
2021-10-29 OXY100
2021-10-29 OXY300
2021-10-29 PCP25
2021-10-29 PGB1000
2021-10-29 PGB500
2021-10-29 PPX300
2021-10-29 SOMA1000
2021-10-29 TAP1000
2021-10-29 TCA1000
2021-10-29 TCA300
2021-10-29 THC150
2021-10-29 THC200
2021-10-29 THC25
2021-10-29 THC300
2021-10-29 THC50
2021-10-29 THC500
2021-10-29 TRA100
2021-10-29 TRA300
2021-10-29 ZOL25
2021-10-29 ZOL50
2021-10-29 ZOP50
2023-08-21 FYL10
2023-08-21 FYL20
2021-10-29 RAPID RESPONSE MULTI-DRUG ONE STEP CUP (URINE) 2021-10-29 6-MAM10
2021-10-29 ACE5000
2021-10-29 ALP100
2021-10-29 AMP1000
2021-10-29 AMP300
2021-10-29 AMP500
2021-10-29 APVP500
2021-10-29 BAR100
2021-10-29 BAR200
2021-10-29 BAR300
2021-10-29 BUP10
2021-10-29 BUP5
2021-10-29 BZO100
2021-10-29 BZO200
2021-10-29 BZO300
2021-10-29 BZO500
2021-10-29 CAF8000
2021-10-29 CFYL500
2021-10-29 CLO150
2021-10-29 COC100
2021-10-29 COC150
2021-10-29 COC200
2021-10-29 COC300
2021-10-29 COT100
2021-10-29 COT1000
2021-10-29 COT200
2021-10-29 COT300
2021-10-29 COT600
2021-10-29 D-1F-107
2021-10-29 D-1F1-107
2021-10-29 D-1F10-107
2021-10-29 D-1F11-107
2021-10-29 D-1F12-107
2021-10-29 D-1F13-107
2021-10-29 D-1F14-107
2021-10-29 D-1F2-107
2021-10-29 D-1F3-107
2021-10-29 D-1F4-107
2021-10-29 D-1F5-107
2021-10-29 D-1F6-107
2021-10-29 D-1F7-107
2021-10-29 D-1F8-107
2021-10-29 D-1F9-107
2021-10-29 D-1U1-107
2021-10-29 D-1U10-107
2021-10-29 D-1U11-107
2021-10-29 D-1U12-107
2021-10-29 D-1U13-107
2021-10-29 D-1U14-107
2021-10-29 D-1U2-107
2021-10-29 D-1U3-107
2021-10-29 D-1U4-107
2021-10-29 D-1U5-107
2021-10-29 D-1U6-107
2021-10-29 D-1U7-107
2021-10-29 D-1U8-107
2021-10-29 D-1U9-107
2021-10-29 D-1V1-107
2021-10-29 D-1V10-107
2021-10-29 D-1V11-107
2021-10-29 D-1V12-107
2021-10-29 D-1V13-107
2021-10-29 D-1V14-107
2021-10-29 D-1V2-107
2021-10-29 D-1V3-107
2021-10-29 D-1V4-107
2021-10-29 D-1V5-107
2021-10-29 D-1V6-107
2021-10-29 D-1V7-107
2021-10-29 D-1V8-107
2021-10-29 D-1V9-107
2021-10-29 DIA100
2021-10-29 EDDP100
2021-10-29 EDDP300
2021-10-29 ETG1000
2021-10-29 ETG300
2021-10-29 ETG500
2021-10-29 GAB2000
2021-10-29 GHB10000
2021-10-29 HMO1000
2021-10-29 HMO250
2021-10-29 HMO500
2021-10-29 K2-30
2021-10-29 K2-50
2021-10-29 K3-25
2021-10-29 K4-25
2021-10-29 KET1000
2021-10-29 KET300
2021-10-29 KET500
2021-10-29 KRA500
2021-10-29 LSD20
2021-10-29 LSD50
2021-10-29 MCAT500
2021-10-29 MDA500
2021-10-29 MDMA1000
2021-10-29 MDMA300
2021-10-29 MDMA500
2021-10-29 MDPHP500
2021-10-29 MDPV1000
2021-10-29 MDPV500
2021-10-29 MEP500
2021-10-29 MES500
2021-10-29 MET1000
2021-10-29 MET300
2021-10-29 MET500
2021-10-29 MOP100
2021-10-29 MOP200
2021-10-29 MOP300
2021-10-29 MPD150
2021-10-29 MPD300
2021-10-29 MQL300
2021-10-29 MTD200
2021-10-29 MTD300
2021-10-29 NFYL20
2021-10-29 OPI1000
2021-10-29 OPI2000
2021-10-29 OXY100
2021-10-29 OXY300
2021-10-29 PCP25
2021-10-29 PGB1000
2021-10-29 PGB500
2021-10-29 PPX300
2021-10-29 SOMA1000
2021-10-29 TAP1000
2021-10-29 TCA1000
2021-10-29 TCA300
2021-10-29 THC150
2021-10-29 THC200
2021-10-29 THC25
2021-10-29 THC300
2021-10-29 THC50
2021-10-29 THC500
2021-10-29 TRA100
2021-10-29 TRA300
2021-10-29 ZOL25
2021-10-29 ZOL50
2021-10-29 ZOP50
2022-07-06 FYL10
2022-07-06 FYL20
2021-10-29 RAPID RESPONSE MULTI-DRUG ONE STEP CUP + ADULTERATION (URINE) 2021-10-29 6-MAM10
2021-10-29 ACE5000
2021-10-29 ALP100
2021-10-29 AMP1000
2021-10-29 AMP300
2021-10-29 AMP500
2021-10-29 APVP500
2021-10-29 BAR100
2021-10-29 BAR200
2021-10-29 BAR300
2021-10-29 BUP10
2021-10-29 BUP5
2021-10-29 BZO100
2021-10-29 BZO200
2021-10-29 BZO300
2021-10-29 BZO500
2021-10-29 CAF8000
2021-10-29 CFYL500
2021-10-29 CLO150
2021-10-29 COC100
2021-10-29 COC150
2021-10-29 COC200
2021-10-29 COC300
2021-10-29 COT100
2021-10-29 COT1000
2021-10-29 COT200
2021-10-29 COT300
2021-10-29 COT600
2021-10-29 D-1F10A-107
2021-10-29 D-1F11A-107
2021-10-29 D-1F12A-107
2021-10-29 D-1F13A-107
2021-10-29 D-1F14A-107
2021-10-29 D-1F1A-107
2021-10-29 D-1F2A-107
2021-10-29 D-1F3A-107
2021-10-29 D-1F4A-107
2021-10-29 D-1F5A-107
2021-10-29 D-1F6A-107
2021-10-29 D-1F7A-107
2021-10-29 D-1F8A-107
2021-10-29 D-1F9A-107
2021-10-29 D-1U10A-107
2021-10-29 D-1U11A-107
2021-10-29 D-1U12A-107
2021-10-29 D-1U13A-107
2021-10-29 D-1U14A-107
2021-10-29 D-1U1A-107
2021-10-29 D-1U2A-107
2021-10-29 D-1U3A-107
2021-10-29 D-1U4A-107
2021-10-29 D-1U5A-107
2021-10-29 D-1U6A-107
2021-10-29 D-1U7A-107
2021-10-29 D-1U8A-107
2021-10-29 D-1U9A-107
2021-10-29 D-1V10A-107
2021-10-29 D-1V11A-107
2021-10-29 D-1V12A-107
2021-10-29 D-1V13A-107
2021-10-29 D-1V14A-107
2021-10-29 D-1V1A-107
2021-10-29 D-1V2A-107
2021-10-29 D-1V3A-107
2021-10-29 D-1V4A-107
2021-10-29 D-1V5A-107
2021-10-29 D-1V6A-107
2021-10-29 D-1V7A-107
2021-10-29 D-1V8A-107
2021-10-29 D-1V9A-107
2021-10-29 D-1VA-107
2021-10-29 DIA100
2021-10-29 EDDP100
2021-10-29 EDDP300
2021-10-29 ETG1000
2021-10-29 ETG300
2021-10-29 ETG500
2021-10-29 GAB2000
2021-10-29 GHB10000
2021-10-29 HMO1000
2021-10-29 HMO250
2021-10-29 HMO500
2021-10-29 K2-30
2021-10-29 K2-50
2021-10-29 K3-25
2021-10-29 K4-25
2021-10-29 KET1000
2021-10-29 KET300
2021-10-29 KET500
2021-10-29 KRA500
2021-10-29 LSD20
2021-10-29 LSD50
2021-10-29 MCAT500
2021-10-29 MDA500
2021-10-29 MDMA1000
2021-10-29 MDMA300
2021-10-29 MDMA500
2021-10-29 MDPHP500
2021-10-29 MDPV1000
2021-10-29 MDPV500
2021-10-29 MEP500
2021-10-29 MES500
2021-10-29 MET1000
2021-10-29 MET300
2021-10-29 MET500
2021-10-29 MOP100
2021-10-29 MOP200
2021-10-29 MOP300
2021-10-29 MPD150
2021-10-29 MPD300
2021-10-29 MQL300
2021-10-29 MTD200
2021-10-29 MTD300
2021-10-29 NFYL20
2021-10-29 OPI1000
2021-10-29 OPI2000
2021-10-29 OXY100
2021-10-29 OXY300
2021-10-29 PCP25
2021-10-29 PGB1000
2021-10-29 PGB500
2021-10-29 PPX300
2021-10-29 SOMA1000
2021-10-29 TAP1000
2021-10-29 TCA1000
2021-10-29 TCA300
2021-10-29 THC150
2021-10-29 THC200
2021-10-29 THC25
2021-10-29 THC300
2021-10-29 THC50
2021-10-29 THC500
2021-10-29 TRA100
2021-10-29 TRA300
2021-10-29 ZOL25
2021-10-29 ZOL50
2021-10-29 ZOP50
2023-08-21 FYL10
2023-08-21 FYL20

Licence No.: 109225

Type: Test Kit
Device class: 2
Device first issue date 2023-04-17
Licence name: RAPID RESPONSE DRUG SCREENING TEST STRIP (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-04-17 RAPID RESPONSE 6- MONOACETYLMORPHINE TEST STRIP (URINE) 2023-04-17 6-MAM10
2023-04-17 RAPID RESPONSE 7- AMINOCLONAZEPAM TEST STRIP (URINE) 2023-04-17 7-ACL200
2023-04-17 7-ACL300
2023-04-17 RAPID RESPONSE ABPINACA SYNTHETIC CANNABINOIDS TEST STRIP (URINE) 2023-04-17 K3 25
2023-04-17 RAPID RESPONSE ACETAMINOPHEN TEST STRIP (URINE) 2023-04-17 ACE5000
2023-04-17 RAPID RESPONSE ALPHA-PYRROLIDINOPENTIOPHENONE TEST STRIP (URINE) 2023-04-17 APVP500
2023-04-17 RAPID RESPONSE ALPRAZOLAM TEST STRIP (URINE) 2023-04-17 ALP100
2023-04-17 RAPID RESPONSE AMPHETAMINE TEST STRIP (URINE) 2023-04-17 AMP1000
2023-04-17 AMP300
2023-04-17 AMP500
2023-04-17 RAPID RESPONSE BARBITURATES TEST STRIP (URINE) 2023-04-17 BAR100
2023-04-17 BAR200
2023-04-17 BAR300
2023-04-17 RAPID RESPONSE BENZODIAZEPINES TEST STRIP (URINE) 2023-04-17 BZO100
2023-04-17 BZO200
2023-04-17 BZO300
2023-04-17 BZO500
2023-04-17 RAPID RESPONSE BUPRENORPHINE TEST STRIP (URINE) 2023-04-17 BUP10
2023-04-17 BUP5
2023-04-17 RAPID RESPONSE CAFFEINE TEST STRIP (URINE) 2023-04-17 CAF8000
2023-04-17 RAPID RESPONSE CARFENTANYL TEST STRIP (URINE) 2023-04-17 CFYL500
2023-04-17 RAPID RESPONSE CARISOPRODOL TEST STRIP (URINE) 2023-04-17 SOMA1000
2023-04-17 RAPID RESPONSE CATHINE TEST STRIP (URINE) 2023-04-17 CAT100
2023-04-17 RAPID RESPONSE CLONAZEPAM TEST STRIP (URINE) 2023-04-17 CLO150
2023-04-17 RAPID RESPONSE COCAINE TEST STRIP (URINE) 2023-04-17 COC100
2023-04-17 COC150
2023-04-17 COC200
2023-04-17 COC300
2023-11-09 COC-1S3-100
2023-04-17 RAPID RESPONSE COTININE TEST STRIP (URINE) 2023-04-17 COT100
2023-04-17 COT1000
2023-04-17 COT200
2023-04-17 COT300
2023-04-17 COT600
2023-04-17 RAPID RESPONSE DIAZEPAM TEST STRIP (URINE) 2023-04-17 DIA100
2023-04-17 RAPID RESPONSE EDDP TEST STRIP (URINE) 2023-04-17 EDDP100
2023-04-17 EDDP300
2023-04-17 RAPID RESPONSE ETHYL GLUCURONIDE TEST STRIP (URINE) 2023-04-17 ETG1000
2023-04-17 ETG300
2023-04-17 ETG500
2023-04-17 RAPID RESPONSE FENTANYL TEST STRIP (URINE) 2023-04-17 FYL10
2023-04-17 FYL20
2023-04-17 RAPID RESPONSE GABAPENTIN TEST STRIP (URINE) 2023-04-17 GAB2000
2023-04-17 RAPID RESPONSE GAMMAHYDROOXYBUTYRIC TEST STRIP (URINE) 2023-04-17 GHB10000
2023-04-17 RAPID RESPONSE HYDROMORPHONE TEST STRIP (URINE) 2023-04-17 HMO1000
2023-04-17 HMO250
2023-04-17 HMO500
2023-04-17 RAPID RESPONSE KETAMINE TEST STRIP (URINE) 2023-04-17 KET1000
2023-04-17 KET300
2023-04-17 KET500
2023-04-17 RAPID RESPONSE KRATOM TEST STRIP (URINE) 2023-04-17 KRA500
2023-04-17 RAPID RESPONSE LYSERGIC ACID DIETHYLAMIDE TEST STRIP (URINE) 2023-04-17 LSD20
2023-04-17 LSD50
2023-04-17 RAPID RESPONSE MARIJUANA TEST STRIP (URINE) 2023-04-17 THC150
2023-04-17 THC200
2023-04-17 THC25
2023-04-17 THC300
2023-04-17 THC50
2023-04-17 THC500
2023-11-09 THC-1S13-100
2023-04-17 RAPID RESPONSE MDMA TEST STRIP (URINE) 2023-04-17 MDMA1000
2023-04-17 MDMA300
2023-04-17 MDMA500
2023-04-17 RAPID RESPONSE MDPHP 500 TEST STRIP (URINE) 2023-04-17 MDPHP500
2023-04-17 RAPID RESPONSE MDPV TEST STRIP (URINE) 2023-04-17 MDPV1000
2023-04-17 MDPV500
2023-04-17 RAPID RESPONSE MEPHEDRONE TEST STRIP (URINE) 2023-04-17 MEP500
2023-04-17 RAPID RESPONSE MESCALINE TEST STRIP (URINE) 2023-04-17 MES500
2023-04-17 RAPID RESPONSE METHADONE TEST STRIP (URINE) 2023-04-17 MTD200
2023-04-17 MTD300
2023-04-17 RAPID RESPONSE METHAMPHETAMINE TEST STRIP (URINE) 2023-04-17 MET1000
2023-04-17 MET300
2023-04-17 MET500
2023-04-17 RAPID RESPONSE METHAQUALONE TEST STRIP (URINE) 2023-04-17 MQL300
2023-04-17 RAPID RESPONSE METHCATHINONE TEST STRIP (URINE) 2023-04-17 MCAT500
2023-04-17 RAPID RESPONSE METHYPHENIDATE TEST STRIP (URINE) 2023-04-17 MPD150
2023-04-17 MPD300
2023-04-17 RAPID RESPONSE MORPHINE TEST STRIP (URINE) 2023-04-17 MOR100
2023-04-17 MOR200
2023-04-17 MOR300
2023-04-17 RAPID RESPONSE NORFENTANYL TEST STRIP (URINE) 2023-04-17 NFYL20
2023-04-17 RAPID RESPONSE OPIATE TEST STRIP (URINE) 2023-04-17 OPI1000
2023-04-17 OPI2000
2023-04-17 RAPID RESPONSE OXYCODONE TEST STRIP (URINE) 2023-04-17 OXY100
2023-04-17 OXY300
2023-04-17 RAPID RESPONSE PHENCYCLIDINE TEST STRIP (URINE) 2023-04-17 PCP25
2023-04-17 RAPID RESPONSE PREGABALIN TEST STRIP (URINE) 2023-04-17 PGB1000
2023-04-17 PGB500
2023-04-17 RAPID RESPONSE PROPOXYPHENE TEST STRIP (URINE) 2023-04-17 PPX300
2023-04-17 RAPID RESPONSE SYNTHETIC MARIJUANA TEST STRIP (URINE) 2023-04-17 K2 25
2023-04-17 K2 30
2023-04-17 K2 50
2023-04-17 RAPID RESPONSE TAPENTADOL TEST STRIP (URINE) 2023-04-17 TAP1000
2023-04-17 RAPID RESPONSE TENAMFETAMINE TEST STRIP (URINE) 2023-04-17 MDA500
2023-04-17 RAPID RESPONSE TILIDINE TEST STRIP (URINE) 2023-04-17 TLD300
2023-04-17 RAPID RESPONSE TRAMADOL TEST STRIP (URINE) 2023-04-17 TRA100
2023-04-17 TRA300
2023-04-17 RAPID RESPONSE TRAZODONE TEST STRIP (URINE) 2023-04-17 TZD200
2023-04-17 RAPID RESPONSE TRICYCLIC ANTIDEPRESSANTS TEST STRIP (URINE) 2023-04-17 TCA1000
2023-04-17 TCA300
2023-04-17 RAPID RESPONSE TROPICAMIDE TEST STRIP (URINE) 2023-04-17 TPM350
2023-04-17 RAPID RESPONSE UR-144 SYNTHETIC CANNABINOIDS TEST STRIP (URINE) 2023-04-17 K4 25
2023-04-17 RAPID RESPONSE XYLAZINE TEST STRIP (URINE) 2023-04-17 XYL1000
2023-04-17 RAPID RESPONSE ZALEPLON TEST STRIP (URINE) 2023-04-17 ZAL100
2023-04-17 RAPID RESPONSE ZOLPIDEM TEST STRIP (URINE) 2023-04-17 ZOL25
2023-04-17 ZOL50
2023-04-17 RAPID RESPONSE ZOPICLONE TEST STRIP (URINE) 2023-04-17 ZOP50

Licence No.: 109283

Type: Test Kit
Device class: 2
Device first issue date 2023-05-01
Licence name: RAPID RESPONSE MULTI DRUG TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-05-01 RAPID RESPONSE MULTI-DRUG TEST CASSETTE 2023-05-01 6-MAM10
2023-05-01 AMP1000
2023-05-01 AMP300
2023-05-01 AMP500
2023-05-01 BAR200
2023-05-01 BAR300
2023-05-01 BUP10
2023-05-01 BUP5
2023-05-01 BZO100
2023-05-01 BZO200
2023-05-01 BZO300
2023-05-01 BZO500
2023-05-01 COC100
2023-05-01 COC300
2023-05-01 COT100
2023-05-01 COT200
2023-05-01 D-1E-08
2023-05-01 EDDP100
2023-05-01 EDDP300
2023-05-01 FYL10
2023-05-01 FYL20
2023-05-01 K2-25
2023-05-01 K2-30
2023-05-01 K2-50
2023-05-01 K3-10
2023-05-01 KET1000
2023-05-01 KET300
2023-05-01 KET500
2023-05-01 MCAT1000
2023-05-01 MDMA1000
2023-05-01 MDMA500
2023-05-01 MDPV1000
2023-05-01 MDPV3000
2023-05-01 MET1000
2023-05-01 MET300
2023-05-01 MET500
2023-05-01 MOP100
2023-05-01 MOP300
2023-05-01 MQL300
2023-05-01 MTD200
2023-05-01 MTD300
2023-05-01 OPI2000
2023-05-01 OXY100
2023-05-01 PCP25
2023-05-01 PPX300
2023-05-01 TCA1000
2023-05-01 THC150
2023-05-01 THC25
2023-05-01 THC50
2023-05-01 TML100
2023-05-01 TRA100
2023-05-01 ZOL50
2023-05-01 ZOP50

Licence No.: 109301

Type: Test Kit
Device class: 3
Device first issue date 2023-05-03
Licence name: RAPID RESPONSE STREP A RAPID TEST DEVICE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-05-03 RAPID RESPONSE STREP A RAPID TEST DEVICE 2023-05-03 STR-15CT20
2023-05-03 STR-15CTC20
2023-09-26 STR-15STC25
2023-05-03 STREP A NEGATIVE CONTROL 2023-05-03 STR-CN
2023-05-03 STREP A POSITIVE CONTROL 2023-05-03 STR-CP

Licence No.: 109633

Type: Test Kit
Device class: 2
Device first issue date 2023-06-22
Licence name: RAPID RESPONSE MULTI DRUG TEST PANEL W/WO ADULTERATIONS (URINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-06-22 RAPID RESPONSE DRUG TEST PANEL (URINE) 2023-06-22 6-MAM10
2023-06-22 7-ACL200
2023-06-22 7-ACL300
2023-06-22 ACE5000
2023-06-22 ALP100
2023-06-22 AMP1000
2023-06-22 AMP300
2023-06-22 AMP500
2023-06-22 APVP500
2023-06-22 BAR100
2023-06-22 BAR200
2023-06-22 BAR300
2023-06-22 BUP10
2023-06-22 BUP5
2023-06-22 BZO100
2023-06-22 BZO200
2023-06-22 BZO300
2023-06-22 BZO500
2023-06-22 CAF8000
2023-06-22 CAT100
2023-06-22 CFYL500
2023-06-22 CLO150
2023-06-22 COC100
2023-06-22 COC150
2023-06-22 COC200
2023-06-22 COC300
2023-06-22 COT100
2023-06-22 COT1000
2023-06-22 COT200
2023-06-22 COT300
2023-06-22 COT600
2023-06-22 DIA100
2023-06-22 EDDP100
2023-06-22 EDDP300
2023-06-22 ETG1000
2023-06-22 ETG300
2023-06-22 ETG500
2023-06-22 FYL10
2023-06-22 FYL20
2023-06-22 GAB2000
2023-06-22 GHB10000
2023-06-22 HMO1000
2023-06-22 HMO250
2023-06-22 HMO500
2023-06-22 K2 25
2023-06-22 K2 30
2023-06-22 K2 50
2023-06-22 K3 25
2023-06-22 K4 25
2023-06-22 KET1000
2023-06-22 KET300
2023-06-22 KET500
2023-06-22 KRA500
2023-06-22 LSD20
2023-06-22 LSD50
2023-06-22 MCAT500
2023-06-22 MDA500
2023-06-22 MDMA1000
2023-06-22 MDMA300
2023-06-22 MDMA500
2023-06-22 MDPHP500
2023-06-22 MDPV1000
2023-06-22 MDPV500
2023-06-22 MEP500
2023-06-22 MES500
2023-06-22 MET1000
2023-06-22 MET300
2023-06-22 MET500
2023-06-22 MOR100
2023-06-22 MOR200
2023-06-22 MOR300
2023-06-22 MPD150
2023-06-22 MPD300
2023-06-22 MQL300
2023-06-22 MTD200
2023-06-22 MTD300
2023-06-22 NFYL20
2023-06-22 OPI1000
2023-06-22 OPI2000
2023-06-22 OXY100
2023-06-22 OXY300
2023-06-22 PCP25
2023-06-22 PGB1000
2023-06-22 PGB500
2023-06-22 PPX300
2023-06-22 SOMA1000
2023-06-22 TAP1000
2023-06-22 TCA1000
2023-06-22 TCA300
2023-06-22 THC150
2023-06-22 THC200
2023-06-22 THC25
2023-06-22 THC300
2023-06-22 THC50
2023-06-22 THC500
2023-06-22 TLD300
2023-06-22 TPM350
2023-06-22 TRA100
2023-06-22 TRA300
2023-06-22 TZD200
2023-06-22 XYL1000
2023-06-22 ZAL100
2023-06-22 ZOL25
2023-06-22 ZOL50
2023-06-22 ZOP50
2023-06-22 RAPID RESPONSE MULTI DRUG TEST PANEL + ADULTERATION TEST (URINE) 2023-06-22 6-MAM10
2023-06-22 7-ACL200
2023-06-22 7-ACL300
2023-06-22 ACE5000
2023-06-22 ALP100
2023-06-22 AMP1000
2023-06-22 AMP300
2023-06-22 AMP500
2023-06-22 APVP500
2023-06-22 BAR100
2023-06-22 BAR200
2023-06-22 BAR300
2023-06-22 BUP10
2023-06-22 BUP5
2023-06-22 BZO100
2023-06-22 BZO200
2023-06-22 BZO300
2023-06-22 BZO500
2023-06-22 CAF8000
2023-06-22 CAT100
2023-06-22 CFYL500
2023-06-22 CLO150
2023-06-22 COC100
2023-06-22 COC150
2023-06-22 COC200
2023-06-22 COC300
2023-06-22 COT100
2023-06-22 COT1000
2023-06-22 COT200
2023-06-22 COT300
2023-06-22 COT600
2023-06-22 CRE/S.G.
2023-06-22 DIA100
2023-06-22 EDDP100
2023-06-22 EDDP300
2023-06-22 ETG1000
2023-06-22 ETG300
2023-06-22 ETG500
2023-06-22 FYL10
2023-06-22 FYL20
2023-06-22 GAB2000
2023-06-22 GHB10000
2023-06-22 HMO1000
2023-06-22 HMO250
2023-06-22 HMO500
2023-06-22 K2 25
2023-06-22 K2 30
2023-06-22 K2 50
2023-06-22 K3 25
2023-06-22 K4 25
2023-06-22 KET1000
2023-06-22 KET300
2023-06-22 KET500
2023-06-22 KRA500
2023-06-22 LSD20
2023-06-22 LSD50
2023-06-22 MCAT500
2023-06-22 MDA500
2023-06-22 MDMA1000
2023-06-22 MDMA300
2023-06-22 MDMA500
2023-06-22 MDPHP500
2023-06-22 MDPV1000
2023-06-22 MDPV500
2023-06-22 MEP500
2023-06-22 MES500
2023-06-22 MET1000
2023-06-22 MET300
2023-06-22 MET500
2023-06-22 MOR100
2023-06-22 MOR200
2023-06-22 MOR300
2023-06-22 MPD150
2023-06-22 MPD300
2023-06-22 MQL300
2023-06-22 MTD200
2023-06-22 MTD300
2023-06-22 NFYL20
2023-06-22 OPI1000
2023-06-22 OPI2000
2023-06-22 OXY100
2023-06-22 OXY300
2023-06-22 PCP25
2023-06-22 PGB1000
2023-06-22 PGB500
2023-06-22 PPX300
2023-06-22 SOMA1000
2023-06-22 TAP1000
2023-06-22 TCA1000
2023-06-22 TCA300
2023-06-22 THC150
2023-06-22 THC200
2023-06-22 THC25
2023-06-22 THC300
2023-06-22 THC50
2023-06-22 THC500
2023-06-22 TLD300
2023-06-22 TPM350
2023-06-22 TRA100
2023-06-22 TRA300
2023-06-22 TZD200
2023-06-22 XYL1000
2023-06-22 ZAL100
2023-06-22 ZOL25
2023-06-22 ZOL50
2023-06-22 ZOP50
2023-06-22 RAPID RESPONSE MULTI-DRUG TEST PANEL (URINE) 2023-06-22 6-MAM10
2023-06-22 7-ACL200
2023-06-22 7-ACL300
2023-06-22 ACE5000
2023-06-22 ALP100
2023-06-22 AMP1000
2023-06-22 AMP300
2023-06-22 AMP500
2023-06-22 APVP500
2023-06-22 BAR100
2023-06-22 BAR200
2023-06-22 BAR300
2023-06-22 BUP10
2023-06-22 BUP5
2023-06-22 BZO100
2023-06-22 BZO200
2023-06-22 BZO300
2023-06-22 BZO500
2023-06-22 CAF8000
2023-06-22 CAT100
2023-06-22 CFYL500
2023-06-22 CLO150
2023-06-22 COC100
2023-06-22 COC150
2023-06-22 COC200
2023-06-22 COC300
2023-06-22 COT100
2023-06-22 COT1000
2023-06-22 COT200
2023-06-22 COT300
2023-06-22 COT600
2023-06-22 DIA100
2023-06-22 EDDP100
2023-06-22 EDDP300
2023-06-22 ETG1000
2023-06-22 ETG300
2023-06-22 ETG500
2023-06-22 FYL10
2023-06-22 FYL20
2023-06-22 GAB2000
2023-06-22 GHB10000
2023-06-22 HMO1000
2023-06-22 HMO250
2023-06-22 HMO500
2023-06-22 K2 25
2023-06-22 K2 30
2023-06-22 K2 50
2023-06-22 K3 25
2023-06-22 K4 25
2023-06-22 KET1000
2023-06-22 KET300
2023-06-22 KET500
2023-06-22 KRA500
2023-06-22 LSD20
2023-06-22 LSD50
2023-06-22 MCAT500
2023-06-22 MDA500
2023-06-22 MDMA1000
2023-06-22 MDMA300
2023-06-22 MDMA500
2023-06-22 MDPHP500
2023-06-22 MDPV1000
2023-06-22 MDPV500
2023-06-22 MEP500
2023-06-22 MES500
2023-06-22 MET1000
2023-06-22 MET300
2023-06-22 MET500
2023-06-22 MOR100
2023-06-22 MOR200
2023-06-22 MOR300
2023-06-22 MPD150
2023-06-22 MPD300
2023-06-22 MQL300
2023-06-22 MTD200
2023-06-22 MTD300
2023-06-22 NFYL20
2023-06-22 OPI1000
2023-06-22 OPI2000
2023-06-22 OXY100
2023-06-22 OXY300
2023-06-22 PCP25
2023-06-22 PGB1000
2023-06-22 PGB500
2023-06-22 PPX300
2023-06-22 SOMA1000
2023-06-22 TAP1000
2023-06-22 TCA1000
2023-06-22 TCA300
2023-06-22 THC150
2023-06-22 THC200
2023-06-22 THC25
2023-06-22 THC300
2023-06-22 THC50
2023-06-22 THC500
2023-06-22 TLD300
2023-06-22 TPM350
2023-06-22 TRA100
2023-06-22 TRA300
2023-06-22 TZD200
2023-06-22 XYL1000
2023-06-22 ZAL100
2023-06-22 ZOL25
2023-06-22 ZOL50
2023-06-22 ZOP50
2023-11-09 D2.1-1P29-25

Licence No.: 109728

Type: Device Family
Device class: 3
Device first issue date 2023-07-11
Licence name: RAPID RESPONSE MARIJUANA (THC) HOME TEST

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-07-11 RAPID RESPONSE MARIJUANA (THC) HOME TEST 2023-07-11 THC-1PGH13
2023-12-08 THC-1PGH13-2
2023-12-08 THC-1PGH13-25
2023-12-08 THC-1PGH13-3
2023-12-08 THC-1PGH13-5

Licence No.: 109744

Type: Test Kit
Device class: 2
Device first issue date 2023-07-14
Licence name: RAPID RESPONSE MALARIA P.F./P.V./PAN TEST CASSETTE (WHOLE BLOOD)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-07-14 RAPID RESPONSE MALARIA P.F./P.V./PAN TEST CASSETTE (WHOLE BLOOD) 2023-07-14 MPV-11C25
2023-07-14 MPV-11C40

Licence No.: 109825

Type: Test Kit
Device class: 2
Device first issue date 2023-07-26
Licence name: RAPID RESPONSE TYPHOID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-07-26 RAPID RESPONSE TYPHOID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA) 2023-07-26 TYP-13C25
2023-07-26 TYP-13C40

Licence No.: 109863

Type: Test Kit
Device class: 2
Device first issue date 2023-08-03
Licence name: RAPID RESPONSE CHAGAS IGG TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-08-03 RAPID RESPONSE CHAGAS IGG TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA) 2023-08-03 CHA-13C25
2023-08-03 CHA-13C40

Licence No.: 109904

Type: Device Family
Device class: 2
Device first issue date 2023-08-16
Licence name: RAPID RESPONSE GIARDIA LAMBLIA TEST CASSETTE (FECES)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-08-16 RAPID RESPONSE GIARDIA LAMBLIA TEST CASSETTE (FECES) 2023-08-16 GLV-9C
2023-08-16 GLV-9C20
2023-08-16 GLV-9C30

Licence No.: 109907

Type: Device Family
Device class: 2
Device first issue date 2023-08-17
Licence name: RAPID RESPONSE RSV TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-08-17 RAPID RESPONSE RSV TEST CASSETTE 2023-08-17 RSV-19C
2023-08-17 RSV-19C20
2023-08-17 RSV-19C30

Licence No.: 109929

Type: Device Family
Device class: 2
Device first issue date 2023-08-24
Licence name: RAPID RESPONSE H. PYLORI TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-08-24 RAPID RESPONSE H. PYLORI TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA) 2023-08-24 HPY-13C
2023-08-24 HPY-13C15
2023-08-24 HPY-13C25
2023-08-24 HPY-13C40

Licence No.: 110279

Type: Test Kit
Device class: 2
Device first issue date 2023-11-02
Licence name: RAPID RESPONSE CRP TEST STRIP (QUAD LINE)

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-11-02 RAPID RESPONSE CRP TEST STRIP (QUAD LINE) 2023-11-02 CRP4-13S
2023-11-02 CRP4-13S20
2023-11-02 CRP4-13S40

Licence No.: 110283

Type: Test Kit
Device class: 2
Device first issue date 2023-11-02
Licence name: RAPID RESPONSE VITAMIN D TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2023-11-02 RAPID RESPONSE VITAMIN D TEST CASSETTE 2023-11-02 VITD-13C1

Licence No.: 110879

Type: Test Kit
Device class: 2
Device first issue date 2024-02-28
Licence name: RAPID RESPONSE LYME IGG/IGM TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-02-28 RAPID RESPONSE LYME IGG/IGM TEST CASSETTE 2024-02-28 LYM-13C20
2024-02-28 LYM-13C40

Licence No.: 111021

Type: Test Kit
Device class: 2
Device first issue date 2024-03-28
Licence name: RAPID RESPONSE SALMONELLA TYPHI/PARATYPHI TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-03-28 RAPID RESPONSE SALMONELLA TYPHI/PARATYPHI TEST CASSETTE 2024-03-28 SAL-9C
2024-03-28 SAL-9C25
2024-03-28 SAL-9C40

Licence No.: 111124

Type: Test Kit
Device class: 2
Device first issue date 2024-04-23
Licence name: RAPID RESPONSE PREGNANCY TEST STRIP

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-04-23 RAPID RESPONSE PREGNANCY TEST STRIP 2024-04-23 HCG-1SH
2024-04-23 HCG-1SH1
2024-04-23 HCG-1SH10
2024-04-23 HCG-1SH100
2024-04-23 HCG-1SH2
2024-04-23 HCG-1SH20
2024-04-23 HCG-1SH25
2024-04-23 HCG-1SH3
2024-04-23 HCG-1SH5
2024-04-23 HCG-1SH50
2024-06-07 RAPID RESPONSE PREGNANCY TEST STRIP WITH URINE COLLECTOR 2024-06-07 HCG-1SHK1
2024-06-07 HCG-1SHK10
2024-06-07 HCG-1SHK100
2024-06-07 HCG-1SHK2
2024-06-07 HCG-1SHK20
2024-06-07 HCG-1SHK25
2024-06-07 HCG-1SHK3
2024-06-07 HCG-1SHK5
2024-06-07 HCG-1SHK50

Licence No.: 111132

Type: Test Kit
Device class: 2
Device first issue date 2024-04-24
Licence name: RAPID RESPONSE RUBELLA TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-04-24 RAPID RESPONSE RUBELLA TEST CASSETTE 2024-04-24 RUB-13C
2024-04-24 RUB-13C25
2024-04-24 RUB-13C40

Licence No.: 111133

Type: Test Kit
Device class: 2
Device first issue date 2024-04-25
Licence name: RAPID RESPONSE MEASLES TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-04-25 RAPID RESPONSE MEASLES TEST CASSETTE 2024-04-25 MEA-13C
2024-04-25 MEA-13C25
2024-04-25 MEA-13C40

Licence No.: 111229

Type: Test Kit
Device class: 2
Device first issue date 2024-05-14
Licence name: RAPID RESPONSE PREGNANCY TEST CASSETTE

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-05-14 RAPID RESPONSE PREGNANCY TEST CASSETTE 2024-05-14 HCG-1CH
2024-05-14 HCG-1CH10
2024-05-14 HCG-1CH100
2024-05-14 HCG-1CH20
2024-05-14 HCG-1CH25
2024-05-14 HCG-1CH5
2024-05-14 HCG-1CH50
2024-06-07 RAPID RESPONSE PREGNANCY TEST CASSETTE WITH URINE COLLECTOR 2024-06-07 HCG-1CHK10
2024-06-07 HCG-1CHK100
2024-06-07 HCG-1CHK20
2024-06-07 HCG-1CHK25
2024-06-07 HCG-1CHK5
2024-06-07 HCG-1CHK50

Licence No.: 111233

Type: Test Kit
Device class: 2
Device first issue date 2024-05-14
Licence name: RAPID RESPONSE PREGNANCY TEST

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-05-14 RAPID RESPONSE PREGNANCY TEST 2024-05-14 HCG-1MNH1
2024-05-14 HCG-1MNH2
2024-05-14 HCG-1MNH25
2024-05-14 HCG-1MNH3
2024-05-14 HCG-1MNH5

Licence No.: 111646

Type: Test Kit
Device class: 2
Device first issue date 2024-08-12
Licence name: RAPID RESPONSE OVULATION TEST STRIP

Device details
Device first issue date Device name Identifier first issue date Device identifier
2024-08-12 RAPID RESPONSE OVULATION TEST STRIP 2024-08-12 LH-1SH
2024-08-12 LH-1SH1
2024-08-12 LH-1SH10
2024-08-12 LH-1SH100
2024-08-12 LH-1SH2
2024-08-12 LH-1SH20
2024-08-12 LH-1SH25
2024-08-12 LH-1SH3
2024-08-12 LH-1SH5
2024-08-12 LH-1SH50
2024-08-12 LH-1SHK1
2024-08-12 LH-1SHK10
2024-08-12 LH-1SHK100
2024-08-12 LH-1SHK2
2024-08-12 LH-1SHK20
2024-08-12 LH-1SHK25
2024-08-12 LH-1SHK3
2024-08-12 LH-1SHK5
2024-08-12 LH-1SHK50

Application information

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