Orient Gene Biotech
Country not established
- Devices
- 1
What Orient Gene Biotech makes
Orient Gene Biotech manufactures the FOB One Step Rapid Test, a diagnostic device designed for point-of-care detection of specific biomarkers or pathogens.
This product is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Fob One Step Rapid Test Ref K110309
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orient Gene Biotech have in the registry?
The registry currently lists 1 device for Orient Gene Biotech. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orient Gene Biotech's devices?
Among its 1 most recently registered device, Orient Gene Biotech has devices listed in FDA 510(k) (1 device).
What risk classes do Orient Gene Biotech's devices fall under?
Among its 1 most recently registered device, the classes recorded for Orient Gene Biotech's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orient Gene Biotech in the registry?
The most recently registered devices listed for Orient Gene Biotech include FOB ONE STEP RAPID TEST.