Identity
- Trade Name
- FilmArray® Gastrointestinal (GI) Panel FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- IVD reagent kit containing 30 tests. FDA UDI
- Model / Reference
- RFIT-ASY-0116 FDA UDI
- Description
- IVD reagent kit containing 30 tests. FDA UDI
Identifiers
- Catalog Number
- RFIT-ASY-0116 FDA UDI
- Primary DI / UDI-DI
- 00815381020109 FDA UDI
- FDA Product Code
- PCH FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3990 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
FilmArray® Gastrointestinal (GI) Panel by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
- QIAstat-Dx® GI Panel 2 Mini B&V — Qiagen, Inc. · Class II
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- Stool Bacterial Pathogens Panel — Great Basin Scientific, Inc. · Class II
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- QIAstat-Dx® Gastrointestinal Panel 2 — Qiagen, Inc. · Class II
- xTAG® Gastrointestinal Pathogen Panel (GPP) — Luminex Molecular Diagnostics, Inc. · Class II
- QIAstat-Dx® GI Panel 2 Mini B — Qiagen, Inc. · Class II
- Shiga Toxin Direct Test — Great Basin Scientific, Inc. · Class II
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Authorization Coverage (1 country)
Regulatory Authorizations
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 28171eb8-0c68-401e-82a4-5e8cbbfbf69c 35 fields · synced Jun 9, 2026