BTNX Inc

Address:722 Rosebank Road,Pickering Ontario,CA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Test, Opiates, Over The Counter (NGL) (3) Test, Phencyclidine (Pcp), Over The Counter (NGM) (3) Test, Amphetamine, Over The Counter (NFT) (3) Test, Cannabinoid, Over The Counter (NFW) (3) Test, Barbiturate, Over The Counter (PTH) (3) Test, Benzodiazepine, Over The Counter (NFV) (3) Test, Methamphetamine, Over The Counter (NGG) (3) Test, Propoxyphene, Over The Counter (QBF) (2) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (2) Test, Methadone, Over The Counter (PTG) (2)

Premarket Exempt

No Yes

Clear

Rapid Response - 10722066005368 Catalog Number :

Device Description : Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO/PCP/PPX) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Cocaine, THC, Phencyclidine and Propoxyphene metabolites in urine.

Device Class : 2

Duns Number: 251005005

Premarket Exempt : No

Product Code : PTH, NFT, NFV, NFW, NFY, NGG, NGL, NGM, PTG, QBF

Prescription Use : Yes

Device Count : 25

Rapid Response - 10722066005641 Catalog Number :

Device Description : 12- Drug Test Panel - 25/kit (12.36) - AMP1000 BAR300 BZO300 COC300 MDMA500 MET1 12- Drug Test Panel - 25/kit (12.36) - AMP1000 BAR300 BZO300 COC300 MDMA500 MET1000 OPI2000 PCP25 THC50 MTD300 OXY100 PPX300.For the detection of drugs in human urine.

Device Class : 2

Duns Number: 251005005

Premarket Exempt : No

Product Code : NFT, NFW, NGG, NGL, NFV, PTH, NGM, PTG, QBF

Prescription Use : Yes

Device Count : 25

Rapid Response - 10722066005658 Catalog Number :

Device Description : Rapid Response Drug Test Panel (8.25) AMP1000 BAR300 BZO300 COC300 MET1000 OPI20 Rapid Response Drug Test Panel (8.25) AMP1000 BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50. For the detection of drugs in human urine. 25 tests/kit.

Device Class : 2

Duns Number: 251005005

Premarket Exempt : No

Product Code : NFT, NFY, NGG, NGL, NFV, PTH, NGM, NFW

Prescription Use : Yes

Device Count : 25

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