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BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane

FDA UDI

Class II (US FDA UDI)

by BioFire Defense, LLC

Identity

Trade Name
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane FDA UDI
Generic Name
Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control FDA UDI
Device Name
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit FDA UDI
Model / Reference
DFA2-ASY-0019 FDA UDI
Description
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit FDA UDI

Identifiers

Catalog Number
DFA2-ASY-0019 FDA UDI
Primary DI / UDI-DI
00851458005280 FDA UDI
510(k) Number
K213362 FDA UDI
FDA Product Code
QVR FDA UDI
QMV FDA UDI
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
866.4000 FDA UDI
866.3966 FDA UDI
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® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane by BioFire Defense, LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control.

Cleared under the same submission

K213362 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 102fbd63-1162-478b-84a6-e21e010573c4 36 fields · synced Jun 1, 2026