Quest Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Quest Diagnostics, Inc. makes
The company develops and provides diagnostic tests for detecting drug metabolites in hair and urine samples, including immunoassays for cocaine, THC, methamphetamine, opiates, and amphetamines. These tests are designed for clinical and forensic use to identify substance use patterns over extended periods. The portfolio includes hair analysis kits for multiple substances and enzyme-linked immunosorbent assays (EIA) for urine-based testing.
The devices fall under FDA Class II and Unclassified (U) regulatory categories, with some listed via the 510(k) premarket notification process. They are registered in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Quest Diagnostics Haircheck-Dt (Pcp Ref K042726
Regimes: 510(k) Registry: 510(k)Quest Diagnostics Urine Cocaine Metabolite Eia Ref K062929
Regimes: 510(k) Registry: 510(k)Quest Diagnostics Haircheck-Dt (Thc) Ref K040257
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Aml Haircheck-Dt (Cocaine) Ref K023626
Regimes: 510(k) Registry: 510(k)Quest Diagnostics Haircheck-Dt (Amphetamines) Ref K051161
Regimes: 510(k) Registry: 510(k)Quest Diagnostics Haircheck-Dt (Opiates) Ref K042725
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quest Diagnostics, Inc. have in the registry?
The registry currently lists 7 devices for Quest Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quest Diagnostics, Inc.'s devices?
Among its 7 most recently registered devices, Quest Diagnostics, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Quest Diagnostics, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Quest Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quest Diagnostics, Inc. in the registry?
The most recently registered devices listed for Quest Diagnostics, Inc. include QUEST DIAGNOSTICS HAIRCHECK-DT (PCP, QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA, QUEST DIAGNOSTICS HAIRCHECK-DT (THC) and QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA.