Quest Diagnostics HairCheck-DT (Cocaine)
Quest Diagnostics Incorporated
Quest Diagnostics Nichols Institute
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007521501 | 3007521501 | Quest Diagnostics Nichols Institute | 1 | N | 2026-01-01 | 33608 Ortega Hwy San Juan Capistrano CA US 92675 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 100297 | 1419014153 | P250002 | Quest Diagnostics AAVrh74 Antibody ELISA CDx | QWQ | 2025-07-24 |
PMN#
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA
Quest Diagnostics, Inc.
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
QUEST DIAGNOSTICS, INC.
QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
Quest Diagnostics, Inc.
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
QUEST DIAGNOSTICS, INC.
QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)
QUEST DIAGNOSTICS, INC.
QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
QUEST DIAGNOSTICS, INC.
AML HAIRCHECK-DT (COCAINE)
QUEST DIAGNOSTICS, INC.
GUDID#
K-QUE-ACT-001-PR - QCard Collection Kit K-QUE-ACT-001-PR is a collection kit that will be distributed in Puerto Rico. This kit is the same as K-QUE-ACT-001 with the difference that it includes a product insert/instructions that are in Spanish.
2026-05-01
K-QUE-ACT-001 REV002 - QCard Blood Collection Kit (WHS)
2026-02-25
K-QUE-ACT-003 REV002 - QCard Collection Kit (WHS)
2026-02-25
K-QUE-ACT-004 REV002 - QCard Collection Kit
2026-02-25
K-QUE-ACT-005 REV002 - QCard Collection Kit (WHS)
2026-02-25
K-QUE-ACT-006 REV001 - QCard Collection Kit (WHS)
2026-02-25
K-QUE-ACT-007 REV000 - QCard Collection Kit (WHS)
2026-02-25
K-QUE-KED-001 REV000 - QCard Collection Kit
2026-02-25
US Blood And Urine Kit - Exempt
2024-05-01
Blood Specimen Collection Kit (EPH) - The Tasso+ Kit is a kit that includes the Tasso+ device and all supplies necessary to collect a blood sample. The Tasso+ device is a sterile, disposable blood lancing device. When collecting a sample, the device is held onto the skin by a mild adhesive. A sterile lancet punctures the skin with a press of the button, simultaneously this creates a slight vacuum that helps capillary blood flow under gravity into a compatible tube. After a predefined time period, or when the tube is full, the device is peeled off the skin. The tube is removed and capped for transport. The lancet is single use and automatically retracts into the device in a safe position after use.
2023-08-23
HairCheck-DT (THC) - 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.
2016-09-23
Express ResultsTM - UDOA-10CA-0503-01
2016-09-24
US Paramed Collection Oral Fluid Kit - Exempt
2024-05-01
US Urine Examiner Kit - Exempt
2024-05-01
US Blood And Urine Kit - Exempt
2024-05-01
US Paramed Collection Oral Fluid Kit - Exempt
2024-05-01
US Urine Examiner Kit - Exempt
2024-05-01
Quest Diagnostics Oral Fluid Oxycodone HEIA - PVH-Exempt
2017-10-02
US Agent Collection Oral Fluid Kit - Exempt
2024-01-15
Express ResultsTM - UDOA-6CA-0503-01
2016-09-24
Express ResultsTM - UDOA-12CE-0712-01
2016-09-24
Multi Use 9 drug (CASE) - DUE-197-232 (FUO)
2023-12-22
Multi Use 9 drug (CASE) - DUE-197-232 (FUO)
2023-12-22
Express ResultsTM - DOA-154-181
2016-09-24
General Purpose Reagent Delayed Semen Analysis Media - Delayed Semen Analysis Collection Cup and Pipette
2023-07-11
HairCheck-DT (THC) Exempt - 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.
2023-07-11
HairCheck-DT (Amphetamines) - 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.
2016-09-23
Express ResultsTM - DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
2022-03-28
Express ResultsTM - DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+<PPX> 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN 10869419000219)
2022-03-28
Express ResultsTM - DOA-154-181(COC/AMP/THC/OPI/PCP)MULTI-DRUG 5 PANEL SCREEN TEST (DOA-154-181) previous (GTIN 10869419000240)
2022-03-28
Express ResultsTM - UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
2022-03-28
Express ResultsTM - UDOA-10CE-1307-01
2016-09-24
Express ResultsTM - DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
2022-03-28
Express ResultsTM - DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+<PPX> 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN 10869419000219)
2022-03-28
Express ResultsTM - DOA-154-181(COC/AMP/THC/OPI/PCP)MULTI-DRUG 5 PANEL SCREEN TEST (DOA-154-181) previous (GTIN 10869419000240)
2022-03-28
Express ResultsTM - UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
2022-03-28
HairCheck-DT (Cocaine) - 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.
2016-12-19
HairCheck-DT (Opiates) - 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.
2016-09-23
HairCheck-DT (PCP) - 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.
2016-09-23
HairCheck-DT Methamphetamine - 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.
2018-06-08