New Bay Bioresearch Co., Ltd.
Country not established
- Devices
- 1
What New Bay Bioresearch Co., Ltd. makes
New Bay Bioresearch Co., Ltd. manufactures the FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST, a diagnostic device used for detecting hidden blood in stool samples to aid in colorectal cancer screening.
This product is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does New Bay Bioresearch Co., Ltd. have in the registry?
The registry currently lists 1 device for New Bay Bioresearch Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list New Bay Bioresearch Co., Ltd.'s devices?
Among its 1 most recently registered device, New Bay Bioresearch Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do New Bay Bioresearch Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for New Bay Bioresearch Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from New Bay Bioresearch Co., Ltd. in the registry?
The most recently registered devices listed for New Bay Bioresearch Co., Ltd. include FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST.