FDA Registration
Active
🇺🇸 United States
FilmArray Meningitis/Encephalitis (ME) Panel
Reg #: 3002773840
·
FEI: 3002773840
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BioFire Diagnostics, LLC
- Registration Number
- 3002773840
- FEI Number
- 3002773840
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 515 Colorow Drive
- City
- Salt Lake City
- State
- UT
- ZIP
- 84108
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN150013
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 |
|---|---|---|---|---|---|
| Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | PLO | Class 2 | Microbiology | No | 2015-11-04 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2015-11-04 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2015-11-04 |
Proprietary Names
FilmArray Meningitis/Encephalitis (ME) Panel
Establishment Types
Manufacture Medical Device