Ani Biotech Oy
Country not established
- Devices
- 1
What Ani Biotech Oy makes
Ani Biotech OY manufactures the MYSET Pregnancy Test, a diagnostic device designed to detect human chorionic gonadotropin (hCG) in urine for pregnancy confirmation.
The MYSET Pregnancy Test is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Myset Pregnancy Test Ref K053138
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ani Biotech OY have in the registry?
The registry currently lists 1 device for Ani Biotech OY. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ani Biotech OY's devices?
Among its 1 most recently registered device, Ani Biotech OY has devices listed in FDA 510(k) (1 device).
What risk classes do Ani Biotech OY's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ani Biotech OY's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ani Biotech OY in the registry?
The most recently registered devices listed for Ani Biotech OY include MYSET PREGNANCY TEST.