Identity
- Trade Name
- FilmArray® Respiratory Panel 2 plus (RP2plus) 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-0137 FDA UDI
- Description
- IVD reagent kit containing 6 tests FDA UDI
Identifiers
- Catalog Number
- RFIT-ASY-0137 FDA UDI
- Primary DI / UDI-DI
- 00815381020307 FDA UDI
- FDA Product Code
- OOI FDA UDINSU FDA UDIPZF 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
- 862.2570 FDA UDI866.4001 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 2 plus (RP2plus) 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 05d11f73-ac00-4478-8773-6259c7b76bb3 35 fields · synced Jun 9, 2026