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

Enzyme Immunoassay, Amphetamine (DKZ) (9) Enzyme Immunoassay, Cocaine And Cocaine Metabolites (DIO) (9) Enzyme Immunoassay, Opiates (DJG) (9) Reagents, Test, Tetrahydrocannabinol (DKE) (9) Thin Layer Chromatography, Methamphetamine (DJC) (9) Enzyme Immunoassay, Benzodiazepine (JXM) (8) Gas Chromatography, Methamphetamine (LAF) (6) Enzyme Immunoassay, Methadone (DJR) (6) Gas Chromatography, Opiates (DJF) (5) Enzyme Immunoassay, Barbiturate (DIS) (5) Enzyme Immunoassay, Phencyclidine (LCM) (4) Enzyme Immunoassay, Propoxyphene (JXN) (1) Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. (DOE) (1) Test Reagents For Ethyl Alcohol (DMJ) (1)

Premarket Exempt

Clear

Healgen (Private Label) - 6125C - 00895330002691 Catalog Number :

Device Description : 12-panel CLIA Cup AMP/COC/OXY/THC/PCP/MDMA/MOR/BZO/BAR/MTD/mAMP/BUP

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 254 - 00895330002707 Catalog Number :

Device Description : 5 Panel Dip Card - CLIA COC/AMP/mAMP/THC/OPI

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DJG, DKZ, DJC, DKE, DIO

Prescription Use : No

Device Count : 1

Healgen (Private Label) FLATCUP-2104 - 00895330002714 Catalog Number :

Device Description : 10 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO/BAR/OXY/MDMA/PPX

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : JXN, LAF, DJF, DIS, JXM, DJC, DKZ, DJG, DKE, DIO

Prescription Use : No

Device Count : 1

Healgen (Private Label) FLATCUP-264 - 00895330002721 Catalog Number :

Device Description : 6 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : JXM, DJC, DKZ, DJG, DKE, DIO

Prescription Use : No

Device Count : 1

Healgen (Private Label) FLATCUP-8104 - 00895330002738 Catalog Number :

Device Description : 10 Panel Flat-Cup COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Healgen (Private Label) FLATCUP-8104A3 - 00895330002745 Catalog Number :

Device Description : 10 Panel Flat-Cup w/ADU COC/THC/OPI/AMP/mAMP/BZO/MTD/OXY/MDMA/BUP+A3

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Healgen (Private Label) EtG Urine Dip *300ng - 00895330002752 Catalog Number :

Device Description : EtG Urine Dip *300ng

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DMJ

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 3104C - 00895330002769 Catalog Number :

Device Description : 10 Panel CLIA Cup COC/THC/OPI/AMP/mAMP/BZO/PCP/BAR/MTD/MDMA

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 3104 - 00895330002776 Catalog Number :

Device Description : 10 Panel Dip Card - CLIA - AMP/THC/COC/OPI/PCP/BZO/BARB/MTD/mAMP/MDMA

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

Healgen (Private Label) - 4104 - 00895330002783 Catalog Number :

Device Description : 10 Panel Dip Card - CLIA - AMP/THC/COC/OPI/PCP/BZO/BARB/MTD/mAMP/OXY

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

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