Identity
- Trade Name
- FilmArray® NGDS Warrior Panel FDA UDI
- Generic Name
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests. FDA UDI
- Model / Reference
- NGDS-ASY-0007 FDA UDI
- Description
- FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests. FDA UDI
Identifiers
- Catalog Number
- NGDS-ASY-0007 FDA UDI
- Primary DI / UDI-DI
- 00851458005136 FDA UDI
- 510(k) Number
- K170883 FDA UDI
- FDA Product Code
- PRD FDA UDINSU FDA UDI
- GMDN Term
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Regulation Number
- 862.2570 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
FilmArray® NGDS Warrior Panel by BioFire Defense, LLC — 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, kit, nucleic acid technique (NAT).
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- BioFire Defense, LLC
Sources (1)
- FDA UDI 5d14f47c-2637-4cad-9153-2287e6921a57 36 fields · synced May 31, 2026