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BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel

FDA UDI

Class II (US FDA UDI)

by BioFire Defense, LLC

Identity

Trade Name
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel FDA UDI
Generic Name
Multiple-type tropical pathogen nucleic acid IVD, control FDA UDI
Device Name
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit FDA UDI
Model / Reference
DFA2-ASY-0006 FDA UDI
Description
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit FDA UDI

Identifiers

Catalog Number
DFA2-ASY-0006 FDA UDI
Primary DI / UDI-DI
00851458005259 FDA UDI
510(k) Number
K202382 FDA UDI
K220870 FDA UDI
FDA Product Code
PMN FDA UDI
GMDN Term
Multiple-type tropical 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 tropical pathogen nucleic acid IVD, control

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel by BioFire Defense, LLC — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K220870 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 4ce4946c-7539-48a4-9f67-a962a458f317 36 fields · synced Jun 7, 2026