Genix Biotek, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Genix Biotek, Inc. makes
Genix Biotek, Inc. manufactures lateral flow immunoassay devices for detecting human chorionic gonadotropin (hCG) in urine, including the ACCULINE Pregnancy Test and the ACCUPACK Pregnancy Test. These products are designed for home use to confirm pregnancy through a visual result within minutes.
The company’s portfolio is regulated as Class II medical devices in the US, with products authorised via the FDA’s 510(k) clearance process. The devices are listed in the FDA’s 510(k) database under Genix Biotek, Inc., which is based in the United States.
Catalogue
Acculine Pregnancy Test Ref K971122
Regimes: 510(k) Registry: 510(k)Accupack Pregnancy Test Ref K964633
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genix Biotek, Inc. have in the registry?
The registry currently lists 2 devices for Genix Biotek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genix Biotek, Inc.'s devices?
Among its 2 most recently registered devices, Genix Biotek, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Genix Biotek, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Genix Biotek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genix Biotek, Inc. in the registry?
The most recently registered devices listed for Genix Biotek, Inc. include ACCULINE PREGNANCY TEST and ACCUPACK PREGNANCY TEST.