Biocon, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Biocon, Inc. makes
Biocon, Inc. manufactures human diploid cell lines, including HEP-2, MRC-5, and WI-38 cells, used primarily for virological testing and vaccine production.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Hep-2 Cells Ref K833360
Regimes: 510(k) Registry: 510(k)Mrc-5 Cells Ref K833358
Regimes: 510(k) Registry: 510(k)Wi-38 Cells Ref K833359
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biocon, Inc. have in the registry?
The registry currently lists 3 devices for Biocon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocon, Inc.'s devices?
Among its 3 most recently registered devices, Biocon, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Biocon, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Biocon, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Biocon, Inc. in the registry?
The most recently registered devices listed for Biocon, Inc. include HEP-2 CELLS, MRC-5 CELLS and WI-38 CELLS.