Biotest-Serum-Institut
Country not established
- Devices
- 2
What Biotest-Serum-Institut makes
Biotest-Serum-Institut manufactures anti-GM and anti-KM typing serums for blood typing applications, as well as microfiltration sets (MF10) designed for sterile filtration processes in medical and laboratory settings.
Their products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Anti-Gm & Anti-Km Typing Serums Ref K812076
Regimes: 510(k) Registry: 510(k)Microfiltration Set MF10 Ref K770253
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotest-Serum-Institut have in the registry?
The registry currently lists 2 devices for Biotest-Serum-Institut. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotest-Serum-Institut's devices?
Among its 2 most recently registered devices, Biotest-Serum-Institut has devices listed in FDA 510(k) (2 devices).
What risk classes do Biotest-Serum-Institut's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biotest-Serum-Institut's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotest-Serum-Institut in the registry?
The most recently registered devices listed for Biotest-Serum-Institut include ANTI-GM & ANTI-KM TYPING SERUMS and MICROFILTRATION SET MF10.