Identity
- Trade Name
- BioFire Warrior Panel Control Kit FDA UDI
- Generic Name
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control FDA UDI
- Device Name
- IVD Reagent External Control Kit for the BioFire Warrior Panel FDA UDI
- Model / Reference
- DFA2-ASY-0047 FDA UDI
- Description
- IVD Reagent External Control Kit for the BioFire Warrior Panel FDA UDI
Identifiers
- Catalog Number
- DFA2-ASY-0047 FDA UDI
- Primary DI / UDI-DI
- 00851458005310 FDA UDI
- 510(k) Number
- K243822 FDA UDI
- FDA Product Code
- PMN FDA UDI
- GMDN Term
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control
BioFire Warrior Panel Control Kit by BioFire Defense, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control.
Cleared under the same submission
K243822 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioFire Defense, LLC
Sources (1)
- FDA UDI 91d9d525-cbb2-4aaa-aa24-0abe3cae33b8 36 fields · synced May 30, 2026