Identity
- Trade Name
- FilmArray® Pneumonia Panel (Pneumo) 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-0145 FDA UDI
- Description
- IVD reagent kit containing 6 tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815381020185 FDA UDI
- FDA Product Code
- QDP 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
- 866.3985 FDA UDI
- Commercial Distribution
- 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
Category: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
FilmArray® Pneumonia Panel (Pneumo) by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
- GeneXpert® — CEPHEID · Class II
- LIAISON PLEX® Respiratory Flex Assay Kit — Luminex Corporation · Class II
- QIAstat-Dx® Respiratory Panel Mini — Qiagen, Inc. · Class II
- BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel — BioFire Diagnostics, LLC · Class II
- FilmArray® Pneumonia Panel plus (Pneumoplus) — BioFire Diagnostics, LLC · Class II
- BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini — BioFire Diagnostics, LLC · Class II
- BioFire® Respiratory Panel 2.1 — BioFire Diagnostics, LLC · Class II
- BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini — BioFire Diagnostics, LLC · Class II
Cleared under the same submission
K180966 also covers:
K212727 also covers:
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 d618448c-a291-4a00-9b72-12b385e05667 34 fields · synced Jun 9, 2026