Wholepower Biotech Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Wholepower Biotech Co., Ltd. makes
Wholepower Biotech Co., Ltd. manufactures rapid diagnostic tests for detecting pregnancy, including cassette, strip, and midstream formats. These devices provide qualitative results for human chorionic gonadotropin (hCG) in urine samples, intended for home or point-of-care use.
The company’s pregnancy tests are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wholepower Biotech Co., Ltd. have in the registry?
The registry currently lists 1 device for Wholepower Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wholepower Biotech Co., Ltd.'s devices?
Among its 1 most recently registered device, Wholepower Biotech Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Wholepower Biotech Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Wholepower Biotech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wholepower Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Wholepower Biotech Co., Ltd. include WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream.