Bdt Ent.
Country not established
- Devices
- 1
What Bdt Ent. makes
Bdt Ent. manufactures the HLA-2000, a device designed for histocompatibility testing to assess tissue compatibility for transplantation procedures. This product aids in matching donor and recipient tissues to reduce the risk of rejection in organ and tissue transplants.
The HLA-2000 is classified as a Class II medical device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Hla-2000 Ref K790513
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bdt Ent. have in the registry?
The registry currently lists 1 device for Bdt Ent.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bdt Ent.'s devices?
Among its 1 most recently registered device, Bdt Ent. has devices listed in FDA 510(k) (1 device).
What risk classes do Bdt Ent.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bdt Ent.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bdt Ent. in the registry?
The most recently registered devices listed for Bdt Ent. include HLA-2000.