Bio Focus Co., Lt.
Country not established
- Devices
- 1
What Bio Focus Co., Lt. makes
Bio Focus Co., Lt. manufactures the PURE-AID PREGNANCY TEST, a diagnostic device designed to detect pregnancy through urine analysis.
The PURE-AID PREGNANCY TEST is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Pure-Aid Pregnancy Test Ref K053452
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio Focus Co., Lt. have in the registry?
The registry currently lists 1 device for Bio Focus Co., Lt.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio Focus Co., Lt.'s devices?
Among its 1 most recently registered device, Bio Focus Co., Lt. has devices listed in FDA 510(k) (1 device).
What risk classes do Bio Focus Co., Lt.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bio Focus Co., Lt.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio Focus Co., Lt. in the registry?
The most recently registered devices listed for Bio Focus Co., Lt. include PURE-AID PREGNANCY TEST.