FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFire® Blood Culture Identification 2 (BCID2) Panel
DI: 00815381020338
·
Model: RFIT-ASY-0147
·
BIOFIRE DIAGNOSTICS, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioFire® Blood Culture Identification 2 (BCID2) Panel
- Primary DI
- 00815381020338
- Version / Model
- RFIT-ASY-0147
- Company Name
- BIOFIRE DIAGNOSTICS, LLC
- Labeler DUNS
- 079280262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 3
- Public Version Date
- 2023-08-11
- Public Version Status
- Update
- Public Device Record Key
- 8e484770-e245-48a4-8408-ab4ba0f5bf94
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 |
|---|---|---|---|---|
| PAM | Gram-Positive Bacteria And Their Resistance Markers | Microbiology | 866.3365 | 2 |
| PEO | Fungal Organisms, Nucleic Acid-Based Assay | Microbiology | 866.3365 | 2 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | Microbiology | 866.3365 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61308 | Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid amplification/mass spectrometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815381020338 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193519 | 000 |