Tissue Culture Biotec, Inc.
Country not established
- Devices
- 1
What Tissue Culture Biotec, Inc. makes
Tissue Culture Biotec, Inc. manufactures the HEP-2 Antinuclear Antibody Test System, a diagnostic device used for detecting antinuclear antibodies in serum samples to aid in the identification of autoimmune diseases.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
Hep-2 Antinuclear Antibody Test System Ref K926114
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tissue Culture Biotec, Inc. have in the registry?
The registry currently lists 1 device for Tissue Culture Biotec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tissue Culture Biotec, Inc.'s devices?
Among its 1 most recently registered device, Tissue Culture Biotec, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Tissue Culture Biotec, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Tissue Culture Biotec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tissue Culture Biotec, Inc. in the registry?
The most recently registered devices listed for Tissue Culture Biotec, Inc. include HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM.