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BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- IVD reagent kit containing 6 tests. FDA UDI
- Model / Reference
- 425089 FDA UDI
- Description
- IVD reagent kit containing 6 tests. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815381020963 FDA UDI
- 510(k) Number
- K243885 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
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 gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid 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
- Xpert Norovirus — CEPHEID · Class II
- Stool Bacterial Pathogens Panel — Great Basin Scientific, Inc. · Class II
- BD MAX™ Enteric Viral Panel — BECTON DICKINSON AND COMPANY · Class II
- 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
Cleared under the same submission
K243885 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 8c7cc508-da08-456b-8f27-24cc6d187e24 34 fields · synced Jun 9, 2026