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BioFire Warrior Panel

FDA UDI

by BioFire Defense, LLC

Identity

Trade Name
BioFire 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
NGDS IVD Reagent Biothreat Detection Kit containing 30 tests. FDA UDI
Model / Reference
NGDS-ASY-0018 FDA UDI
Description
NGDS IVD Reagent Biothreat Detection Kit containing 30 tests. FDA UDI

Identifiers

Catalog Number
NGDS-ASY-0018 FDA UDI
Primary DI / UDI-DI
00851458005303 FDA UDI
510(k) Number
K243822 FDA UDI
FDA Product Code
PRD FDA UDI
GMDN Term
Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

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, kit, nucleic acid technique (NAT)

BioFire 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).

Cleared under the same submission

K243822 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioFire Defense, LLC

Sources (1)

  • FDA UDI 2be8c6cd-67f4-4e16-812d-f5ea7311697b 36 fields · synced Jun 7, 2026