FDA Registration
Active
🇺🇸 United States
BioFire Warrior Panel Control Kit
Reg #: 3010770794
·
FEI: 3010770794
·
Expires 2025
Products
2
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BioFire Defense, LLC
- Registration Number
- 3010770794
- FEI Number
- 3010770794
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 79 W 4500 S Ste 14
- City
- Salt Lake City
- State
- UT
- ZIP
- 84107
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243822
Owner / Operator
- Firm Name
- BIOMERIEUX SA
- Operator Number
- 8020790
- Address
- Chemin De L Orme
- City
- Marcy L Etoile
- State
- Rhone
- Postal Code
- 69280
- Country
- FR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2025-03-26 |
| PRD | No | 2025-03-26 |
Proprietary Names
BioFire Warrior Panel Control Kit
BioFire Warrior Panel
Establishment Types
Manufacture Medical Device