Quest Diagnostics

Quest Diagnostics

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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, Cocaine And Cocaine Metabolites (DIO) (4) Enzyme Immunoassay, Amphetamine (DKZ) (3) Enzyme Immunoassay, Opiates (DJG) (3) Enzyme Immunoassay, Phencyclidine (LCM) (3) Enzyme Immunoassay, Cannabinoids (LDJ) (3) Enzyme Immunoassay, Propoxyphene (JXN) (1) Gas Chromatography, Methamphetamine (LAF) (1) Radioimmunoassay, Tricyclic Antidepressant Drugs (LFG) (1) Test, Methamphetamine, Employment And Insurance Testing, Exempt (PVD) (1) Test, Opiates, Employment And Insurance Testing, Exempt (PVH) (1) Calibrators, Drug Specific (DLJ) (1) Thin Layer Chromatography, Methamphetamine (DJC) (1) Drug Mixture Control Materials (DIF) (1) Enzyme Immunoassay, Barbiturate (DIS) (1) Enzyme Immunoassay, Benzodiazepine (JXM) (1) Enzyme Immunoassay, Methadone (DJR) (1)

Premarket Exempt

No Yes

Clear

HairCheck-DT (Cocaine) - 00868586000209 Catalog Number :

Device Description : HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Co HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Cocaine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

Device Class : 1

Duns Number: 189222334

Premarket Exempt : No

Product Code : DIF, DLJ, DIO

Prescription Use : Yes

Device Count : 1

HairCheck-DT (Cocaine) - 00868586000216 Catalog Number :

Device Description : HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Co HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Cocaine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

Device Class : 2

Duns Number: 189222334

Premarket Exempt : No

Product Code : DIO

Prescription Use : Yes

Device Count : 1

HairCheck-DT (Opiates) - 00868586000223 Catalog Number :

Device Description : HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of op HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of opiates in head hair with a cutoff of 500 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

Device Class : 2

Duns Number: 189222334

Premarket Exempt : No

Product Code : DJG

Prescription Use : Yes

Device Count : 1

HairCheck-DT (Amphetamines) - 00868586000230 Catalog Number :

Device Description : HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection HairCheck-DT (Amphetamines) is an ELISA test kit used for qualitative detection of amphetamines in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

Device Class : 2

Duns Number: 189222334

Premarket Exempt : No

Product Code : DKZ

Prescription Use : Yes

Device Count : 1

HairCheck-DT (THC) - 00868586000247 Catalog Number :

Device Description : HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-CO HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

Device Class : 2

Duns Number: 189222334

Premarket Exempt : No

Product Code : LDJ

Prescription Use : Yes

Device Count : 1

HairCheck-DT (PCP) - 00868586000254 Catalog Number :

Device Description : HairCheck-DT (PCP) is an ELISA test kit used for qualitative detection of phency HairCheck-DT (PCP) is an ELISA test kit used for qualitative detection of phencyclidine in head hair with a cutoff of 300 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

Device Class : U

Duns Number: 189222334

Premarket Exempt : No

Product Code : LCM

Prescription Use : Yes

Device Count : 1

HairCheck-DT Methamphetamine - 00868586000278 Catalog Number :

Device Description : HairCheck-DT (Methamphetamine) is an ELISA test kit used for qualitative detecti HairCheck-DT (Methamphetamine) is an ELISA test kit used for qualitative detection of Methamphetamines in head hair with a cutoff 300 pg/mg of hair. Kit is comprised of 4 Component packages: Microplates, Conjugate Reagents, Common Reagents and Calibrator/Controls.

Device Class : 2

Duns Number: 189222334

Premarket Exempt : Yes

Product Code : PVD

Prescription Use : Yes

Device Count : 1

Quest Diagnostics Oral Fluid Oxycodone HEIA - 00868586000292 Catalog Number :

Device Description : The Quest Diagnostics Oral Fluid Oxycodone HEIA is a Homogeneous Enzyme Immunoas The Quest Diagnostics Oral Fluid Oxycodone HEIA is a Homogeneous Enzyme Immunoassay (HEIA) for the qualitative detection of Oxycodone in human oral fluid collected with the Oral‐Eze® Oral Fluid Collection System. It is a screening test with a cut off of 30 ng of oxycodone per mL (30 ng/mL) in neat oral fluid. This is an in‐vitro diagnostic device intended for laboratory use only.

Device Class : 2

Duns Number: 189222334

Premarket Exempt : Yes

Product Code : PVH

Prescription Use : Yes

Device Count : 1

Express ResultsTM - 10869419000202 Catalog Number :

Device Class :

Duns Number: 189222334

Premarket Exempt : No

Product Code : LDJ, LCM, LAF, DKZ, DJG, DIO

Prescription Use : No

Device Count : 25

Express ResultsTM - 10869419000219 Catalog Number :

Device Class :

Duns Number: 189222334

Premarket Exempt : No

Product Code : LFG, LDJ, LCM, JXN, JXM, DKZ, DJR, DJG, DJC, DIS, DIO

Prescription Use : No

Device Count : 25

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