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Sign in to claim this brandQuest Diagnostics
US
Last updated May 24, 2026
What Quest Diagnostics makes
The company produces diagnostic test kits for detecting drugs of abuse in urine, oral fluid, and hair, including rapid immunoassay tests and enzyme immunoassays for cannabinoids and their metabolites. It also supplies specimen collection tools such as insulated mailers for transporting biological samples, reusable manual blood lancing devices, and home semen collection kits for fertility testing. Additional offerings include urine pH test kits and delayed semen analysis media for clinical use.
These devices are authorised under FDA regulations, with most falling under Class I or Class II classifications. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US medical device regulations. The company operates primarily within the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- questdiagnostics.com
- —
- —
- [email protected]
- Phone
- 913-577-1784
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 189222334
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| US Urine Examiner Kit | Exempt | FDA UDI | Class I | Active |
| Blood Specimen Collection Kit (EPH) | Exempt | FDA UDI | Class I | Active |
| HairCheck-DT Methamphetamine | PVD-Exempt | FDA UDI | Class II | Unknown |
| HairCheck-DT (PCP) | K042726 | FDA UDI | U | Unknown |
| Express ResultsTM | UDOA-6CA-0503-01 | FDA UDI | Class II | Unknown |
| US Paramed Collection Oral Fluid Kit | Exempt | FDA UDI | Class I | Active |
| Express ResultsTM | UDOA-10CE-1307-01 | FDA UDI | Class II | Active |
| Express ResultsTM | DOA-154-181 | FDA UDI | Class II | Active |
| HairCheck-DT (THC) | K040257 | FDA UDI | Class II | Unknown |
| Express ResultsTM | UDOA-10CA-0503-01 | FDA UDI | Class II | Active |
| HairCheck-DT (Amphetamines) | K051161 | FDA UDI | Class II | Unknown |
| HairCheck-DT (Opiates) | K042725 | FDA UDI | Class II | Unknown |
| Express ResultsTM | UDOA-6CA-0503-01 | FDA UDI | Class II | Active |
| Express ResultsTM | UDOA-10CA-0503-01 | FDA UDI | Class II | Unknown |
| HairCheck-DT (Cocaine) | K152232 | FDA UDI | Class II | Unknown |
| Multi Use 9 drug (CASE) | DUE-197-232 (FUO) | FDA UDI | N/A | Active |
| Express ResultsTM | DOA-154-181 | FDA UDI | Class II | Unknown |
| Express ResultsTM | UDOA-12CE-0712-01 | FDA UDI | Class II | Active |
| HairCheck-DT (Cocaine) | K023626 | FDA UDI | Class I | Unknown |
| HairCheck-DT (THC) Exempt | PVJ-Exempt | FDA UDI | Class II | Active |
| US Agent Collection Oral Fluid Kit | Exempt | FDA UDI | Class I | Active |
| General Purpose Reagent Delayed Semen Analysis Media | PPM | FDA UDI | Class I | Active |
| Quest Diagnostics Oral Fluid Oxycodone HEIA | PVH-Exempt | FDA UDI | Class II | Unknown |
| Express ResultsTM | UDOA-12CE-0712-01 | FDA UDI | Class II | Unknown |
| US Blood And Urine Kit | Exempt | FDA UDI | Class I | Active |
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