FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFire® Joint Infection (JI) Panel
DI: 00815381020192
·
Model: RFIT-ASY-0138
·
BIOFIRE DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioFire® Joint Infection (JI) Panel
- Primary DI
- 00815381020192
- Version / Model
- RFIT-ASY-0138
- Company Name
- BIOFIRE DIAGNOSTICS, LLC
- Labeler DUNS
- 079280262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 1
- Public Version Date
- 2022-07-08
- Public Version Status
- New
- Public Device Record Key
- 0e1befe7-d3f2-4cd5-8036-655f0474a6f8
Device Description
IVD reagent kit containing 30 kits.
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 |
|---|---|---|---|---|
| QSN | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System | Microbiology | 866.3988 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65914 | Multiple-type osteoarticular 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 (e.g., bacteria, viruses, parasites) associated with osteoarticular/joint infection in a clinical specimen (typically synovial fluid), using a nucleic acid technique (NAT). This test detects pathogens which may include Clostridium, Klebsiella, and Salmonella bacteria, and the yeast Candida albicans, and is used to aid the diagnosis of infectious arthritis (septic arthritis) and/or prosthetic joint infection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815381020192 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN200066 | 000 |