Contract manufacturerBiovire, Inc. (Brighton, MI)MichiganPathologyGastroenterology and urologyGeneral hospitalClass IClass II
Biovire, Inc.
Contract manufacturer ยท Brighton, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011292417 (openFDA record; or search FDA's registration database)
- FEI number
- 3011292417
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Biovire, Inc. (FDA owner/operator no. 10059698)
- Registered address
- 12501 E. Grand River, Brighton, MI 48116
- Contract listings
- 4 device listings, 4 product codes, first listed Feb 12, 2019
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| JCC | Ph Buffer | Class I | Pathology | Contract manufacturing | Feb 12, 2019 |
| KDL | Set, Perfusion, Kidney, Disposable | Class II | Gastroenterology and urology | Contract manufacturing | Dec 23, 2019 |
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology and urology | Contract manufacturing | Sep 10, 2019 |
| NEP | System/Device, Pharmacy Compounding | Class II | General hospital | Contract manufacturing | Jun 4, 2025 |