CONFIRM BIOSCIENCES, INC.

Address:9645 Granite Ridge Drive, Suite 200,SAN DIEGO,CA,92123,US

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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

Gas Chromatography, Opiates (DJF) (6) Reagents, Test, Tetrahydrocannabinol (DKE) (6) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (6) Enzyme Immunoassay, Benzodiazepine (JXM) (6) Enzyme Immunoassay, Methadone (DJR) (5) Enzyme Immunoassay, Amphetamine (DKZ) (5) Enzyme Immunoassay, Opiates (DJG) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Thin Layer Chromatography, Methamphetamine (DJC) (4) Enzyme Immunoassay, Phencyclidine (LCM) (4) Gas Chromatography, Methamphetamine (LAF) (4) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (3) Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. (DOE) (2) Test, Cannabinoid, Over The Counter (NFW) (1) Test, Methamphetamine, Over The Counter (NGG) (1) Test, Opiates, Over The Counter (NGL) (1) Test, Cocaine And Cocaine Metabolites, Over The Counter (NFY) (1) Test, Amphetamine, Over The Counter (NFT) (1)

Premarket Exempt

Clear

Healgen (Private Label) - 3124 - 00895330002790 Catalog Number :

Device Description : 12 Panel Dip Card - CLIA - COC,THC,OPI,AMP,PCP,TCA,BZO,BAR,MTD,MDMA,OXY,BUP

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : LFG, DIO, DKE, DJG, LCM, DJF, JXM, DIS, DJR, DKZ, DJC

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 254 - 00895330002806 Catalog Number :

Device Description : 5 Panel Clia Cup COC/THC/OPI/AMP/mAMP

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : NFT, NFY, NGG, NGL, NFW

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 264 - 00895330002813 Catalog Number :

Device Description : 6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : JXM, DJF, DKE, LAF, DKZ, DIO

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 7104 - 00895330002820 Catalog Number :

Device Description : 10 Panel Dip Card - CLIA COC,THC,OPI,BZO,mAMP,TCA,OXY,BUP,BAR,MTD

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : JXM, DJG, LAF, DKE, DIO, DJR, DIS, DJF, LFG

Prescription Use : No

Device Count : 1

Healgen (Private Label) FLATCUP-6125A3 - 00895330002844 Catalog Number :

Device Description : 12 Panel Flat-Cup w/ADU (AMP/COC/OXY/THC/PCP/MDMA/MOR/BZO/BAR/MTD/mAMP/BUP+A3)

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DIS, DJG, DJR, LCM, LAF, DJF, DKZ, JXM, DOE, DIO, DJC, DKE

Prescription Use : No

Device Count : 1

Healgen (Private Label) 6125A3 - 00895330002851 Catalog Number :

Device Description : 12-panel Cup with ADU (AMP/COC/OXY/THC/PCP/MDMA/MOR/BZO/BAR/MTD/mAMP/BUP+A3)

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DKE, DJC, DIO, DOE, JXM, DKZ, DJF, LAF, LCM, DJR, DJG, DIS

Prescription Use : No

Device Count : 1

Helalgen (Private Label) - 3124 - 00895330002868 Catalog Number :

Device Description : 12 Panel Dip Card - CLIA - COC,THC,OPI,AMP,PCP,TCA,BZO,BAR,MTD,MDMA,OXY,BUP

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DIS, DJF, DJC, DJR, JXM, LFG, LCM, DKZ, DJG, DKE, DIO

Prescription Use : No

Device Count : 1

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