Bionike Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Bionike Laboratories, Inc. makes
Bionike Laboratories, Inc. manufactures rapid, single-use lateral flow immunoassay tests for detecting drugs of abuse and pregnancy. Products include tests for PCP, THC, cocaine, morphine, and pregnancy confirmation, designed for point-of-care use in clinical and non-clinical settings.
The company’s portfolio is regulated under FDA Class II and Class U device classifications, with submissions recorded via the 510(k) pathway. Devices are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Bionike Aq Phencyclidine (Pcp) Test Ref K993945
Regimes: 510(k) Registry: 510(k)Bionike Aq One Step Cannabinoids (Thc) Test Ref K971841
Regimes: 510(k) Registry: 510(k)Bionike A/Q Pregnancy Test Ref K954901
Regimes: 510(k) Registry: 510(k)Aq One Step Cocaine Test Ref K972384
Regimes: 510(k) Registry: 510(k)Aq Opiates (Morphine) Test Ref K971361
Regimes: 510(k) Registry: 510(k)Bionike A/Q Pregnancy Test Ref K960992
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bionike Laboratories, Inc. have in the registry?
The registry currently lists 6 devices for Bionike Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bionike Laboratories, Inc.'s devices?
Among its 6 most recently registered devices, Bionike Laboratories, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Bionike Laboratories, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bionike Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bionike Laboratories, Inc. in the registry?
The most recently registered devices listed for Bionike Laboratories, Inc. include BIONIKE AQ PHENCYCLIDINE (PCP) TEST, BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST, BIONIKE A/Q PREGNANCY TEST and AQ ONE STEP COCAINE TEST.