FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
DI: 00815381020765
·
Model: 424589
·
BIOFIRE DIAGNOSTICS, LLC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
- Primary DI
- 00815381020765
- Version / Model
- 424589
- Company Name
- BIOFIRE DIAGNOSTICS, LLC
- Labeler DUNS
- 079280262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-09
- Public Version
- 1
- Public Version Date
- 2023-05-17
- Public Version Status
- New
- Public Device Record Key
- bc1f446d-3d22-445d-b70e-aa4aa2ba6d0e
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 |
|---|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Microbiology | 866.3981 | 2 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | Microbiology | 866.3980 | 2 |
| OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | Microbiology | 866.3980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61527 | Multiple-type respiratory 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 (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815381020765 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230719 | 000 |