CONFIRM BIOSCIENCES, INC.

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

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

Premarket Exempt

No

Clear

Healgen (Private Label) - 242 - 00856464008348 Catalog Number :

Device Description : Healgen (DrugConfirm) 242 - 4 panel Cup AMP1000/COC300/MET1000/OPI2000

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DIO, DKZ, LAF, DJG

Prescription Use : No

Device Count : 1

DrugConfirm - 00856464008409 Catalog Number :

Device Description : 4 Drugs Tested Home Drug Test

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : NFY, NGG, NGL, NFW

Prescription Use : No

Device Count : 1

DrugConfirm - 00856464008423 Catalog Number :

Device Description : 7 Drugs Tested Home Drug Test

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugConfirm - 00856464008430 Catalog Number :

Device Description : 14 Drugs Tested Home Drug Test

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugConfirm - 00856464008447 Catalog Number :

Device Description : 1 Drug Tested Home Drug Test (COC)

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : NFY

Prescription Use : No

Device Count : 1

HealthConfirm - 00856464008683 Catalog Number :

Device Description : This test has not been FDA cleared or approved. This test has been authorized by This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by Clinical Reference Laboratory, Inc. located in Lenexa, KS. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

Device Class :

Duns Number: 806524968

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

DrugConfirm Advanced™ 6 Panel Instant Drug Test - 00895330002073 Catalog Number :

Device Description : This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetami This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetamines (mAMP), Amphetamines (AMP), Phencyclidine (PCP)

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DKE, LCM, DOE, DJC, DIO, DKZ

Prescription Use : No

Device Count : 1

DrugConfirm™ Single Panel Marijuana Testing Kit - 00895330002264 Catalog Number :

Device Description : DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that wan DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which is easy to perform from the privacy of your home to detect marijuana usage.

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DKE

Prescription Use : No

Device Count : 1

DrugConfirm™ 12 Panel Instant Drug Test - 00895330002288 Catalog Number :

Device Description : his kit tests for 12 Drugs including Prescription Drugs: 7 Illicit Drugs his kit tests for 12 Drugs including Prescription Drugs: 7 Illicit Drugs Marijuana, Cocaine, Opiates (Heroin), Methamphetamine, Ecstasy, Amphetamine, Phencyclidine (PCP) 5 Prescription Drugs Tricyclic Antidepressants, Barbiturates, Benzodiazepines, Methadone, Oxycodone

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

DrugConfirm™ 4 Panel Instant Drug Test - 00895330002318 Catalog Number :

Device Description : This urine test kit detects 4 drugs: Cocaine (COC), Marijuana (THC), Opiates (OP This urine test kit detects 4 drugs: Cocaine (COC), Marijuana (THC), Opiates (OPI) including Heroin, Amphetamines (AMP)

Device Class : 2

Duns Number: 806524968

Premarket Exempt : No

Product Code : DKZ, DOE, DKE, DIO

Prescription Use : No

Device Count : 1

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