Biotest Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Biotest Diagnostics Corp. makes
Biotest Diagnostics Corp. manufactures in vitro diagnostic tests for detecting and monitoring viral infections, including kits for cytomegalovirus (CMV) antigenemia and recombinant tests for Epstein-Barr virus (EBV) antibodies (IgG, IgM, and EA). These tests support clinical decision-making in infectious disease management.
The company’s diagnostic products are regulated under FDA’s Class I and Class II device classifications, with some cleared via the 510(k) pathway. They are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Cmv Brite Turbo Kit Ref K991650
Regimes: 510(k) Registry: 510(k)Cmv Brite Antigenemia Test Kit Ref K951550
Regimes: 510(k) Registry: 510(k)Biotest Anti-Ebv Recombinant, Ebna Igg Ref K983841
Regimes: 510(k) Registry: 510(k)Biotest Anti-Ebv Recombinant Ref K983839
Regimes: 510(k) Registry: 510(k)Biotest Anti-Ebv Recombinant, Ea Igm Ref K983842
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotest Diagnostics Corp. have in the registry?
The registry currently lists 5 devices for Biotest Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotest Diagnostics Corp.'s devices?
Among its 5 most recently registered devices, Biotest Diagnostics Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Biotest Diagnostics Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Biotest Diagnostics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotest Diagnostics Corp. in the registry?
The most recently registered devices listed for Biotest Diagnostics Corp. include CMV BRITE TURBO KIT, CMV BRITE ANTIGENEMIA TEST KIT, BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG and BIOTEST ANTI-EBV RECOMBINANT.