FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFire Warrior Panel Control Kit
DI: 00851458005310
·
Model: DFA2-ASY-0047
·
BIOFIRE DEFENSE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioFire Warrior Panel Control Kit
- Primary DI
- 00851458005310
- Version / Model
- DFA2-ASY-0047
- Catalog Number
- DFA2-ASY-0047
- Company Name
- BIOFIRE DEFENSE, LLC
- Labeler DUNS
- 556915205
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-10
- Public Version
- 1
- Public Version Date
- 2025-08-18
- Public Version Status
- New
- Public Device Record Key
- 91d9d525-cbb2-4aaa-aa24-0abe3cae33b8
Device Description
IVD Reagent External Control Kit for the BioFire Warrior Panel
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 |
|---|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | Microbiology | 866.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66859 | Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., bacteria and viruses such as Bacillus anthracis, Francisella tularensis, Yersinia pestis, Ebola virus, influenza A virus) associated with biothreat/febrile infection in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851458005310 | GS1 |
Customer Contacts
- Phone
- 801-262-3592
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243822 | 000 |