FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid
DI: 00815381020888
·
Model: 424898
·
BIOFIRE DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid
- Primary DI
- 00815381020888
- Version / Model
- 424898
- Company Name
- BIOFIRE DIAGNOSTICS, LLC
- Labeler DUNS
- 079280262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-18
- Public Version
- 1
- Public Version Date
- 2025-02-26
- Public Version Status
- New
- Public Device Record Key
- c2a2167f-ab31-432a-b7d9-115af3ce11aa
Device Description
IVD reagent kit containing 30 tests.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | Microbiology | 866.3990 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61058 | Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815381020888 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243885 | 000 |