Bio-Reagents & Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Ldh Isoenzyme Control Ref K771894
Regimes: 510(k) Registry: 510(k)Anticonvulsant Control Serum Ref K760730
Regimes: 510(k) Registry: 510(k)Cpk Isoenzyme Control Ref K770555
Regimes: 510(k) Registry: 510(k)Calibrator, Bovine Serum Ref K781702
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bio-Reagents & Diagnostics, Inc. have in the registry?
The registry currently lists 4 devices for Bio-Reagents & Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio-Reagents & Diagnostics, Inc.'s devices?
Among its 4 most recently registered devices, Bio-Reagents & Diagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Bio-Reagents & Diagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bio-Reagents & Diagnostics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio-Reagents & Diagnostics, Inc. in the registry?
The most recently registered devices listed for Bio-Reagents & Diagnostics, Inc. include LDH ISOENZYME CONTROL, ANTICONVULSANT CONTROL SERUM, CPK ISOENZYME CONTROL and CALIBRATOR, BOVINE SERUM.