FDA Registration
Active
🇺🇸 United States
BIOFIRE SPOTFIRE Module
Reg #: 3002773840
·
FEI: 3002773840
·
Expires 2025
Products
10
Proprietary Names
3
Establishment Types
1
Classifications
10
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
- K213954
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 |
|---|---|---|---|---|---|
| Influenza A And Influenza B Multiplex Nucleic Acid Assay | OZE | Class 2 | Microbiology | No | 2023-02-13 |
| Bordetella Pertussis Dna Assay System | OZZ | Class 2 | Microbiology | No | 2023-02-13 |
| Respiratory Virus Panel Nucleic Acid Assay System | OCC | Class 2 | Microbiology | No | 2023-02-13 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2023-02-13 |
| Non-Sars Coronavirus Multiplex Nucleic Acid Assay | OTG | Class 2 | Microbiology | No | 2023-02-13 |
| Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | QOF | Class 2 | Microbiology | No | 2023-02-13 |
| Mycoplasma Pneumoniae Dna Assay System | OZX | Class 2 | Microbiology | No | 2023-02-13 |
| Parainfluenza Multiplex Nucleic Acid Assay | OOU | Class 2 | Microbiology | No | 2023-02-13 |
| Human Metapneumovirus (Hmpv) Rna Assay System | OEM | Class 2 | Microbiology | No | 2023-02-13 |
| Chlamydophila Pneumoniae Dna Assay System | OZY | Class 2 | Microbiology | No | 2023-02-13 |
Proprietary Names
BIOFIRE SPOTFIRE Module
BIOFIRE SPOTFIRE Respiratory (R) Panel
BIOFIRE SPOTFIRE Control Station
Establishment Types
Manufacture Medical Device