Quantrx Biomedical Corporation
United StatesFDA applicant, unverified
- Devices
- 4
What Quantrx Biomedical Corporation makes
Quantrx Biomedical Corporation manufactures rapid diagnostic tests for fertility assessment and drug-of-abuse detection, including lateral flow assays for methamphetamine, phencyclidine, and cocaine in urine samples. Their products also include a home-use fertility test for women.
The company’s devices are classified as Class I, Class II, and Unclassified under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Their portfolio is listed in the U.S. Food and Drug Administration’s regulatory database.
Catalogue
Quantrx Female Fertility Test Ref K070484
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quantrx Biomedical Corporation have in the registry?
The registry currently lists 4 devices for Quantrx Biomedical Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quantrx Biomedical Corporation's devices?
Among its 4 most recently registered devices, Quantrx Biomedical Corporation has devices listed in FDA 510(k) (4 devices).
What risk classes do Quantrx Biomedical Corporation's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Quantrx Biomedical Corporation's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quantrx Biomedical Corporation in the registry?
The most recently registered devices listed for Quantrx Biomedical Corporation include QUANTRX FEMALE FERTILITY TEST, RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050, RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 and RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052.