Identity
- Trade Name
- FilmArray® Respiratory Panel (RP) FDA UDI
- Generic Name
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- IVD reagent kit containing 6 tests. FDA UDI
- Model / Reference
- RFIT-ASY-0125 FDA UDI
- Description
- IVD reagent kit containing 6 tests. FDA UDI
Identifiers
- Catalog Number
- RFIT-ASY-0125 FDA UDI
- Primary DI / UDI-DI
- 00815381020079 FDA UDI
- FDA Product Code
- OCC FDA UDIOOU FDA UDIOEP FDA UDIOTG FDA UDIOZZ FDA UDIOZX FDA UDIOEM FDA UDI
- GMDN Term
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FilmArray® Respiratory Panel (RP) by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- BioFire Diagnostics, LLC
Sources (1)
- FDA UDI f2a3fc64-9cf1-4ca3-8a7c-3b38984d57f8 35 fields · synced Jun 9, 2026