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BioFire Defense, LLC

USA · Salt Lake City

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

17listed device types

Class I 0Class II 14Class III 0unclassified 3

plus 13 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States13 registration records, 10 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: BioFire Defense, LLC · BIOFIRE DEFENSE LLC

FDA 510(k) clearances by year

22017

22020

12021

22022

12023

12025

12026

FDA listed device types

showing 8 of 17

PRD 1Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid 1Reagents, 2019-Novel Coronavirus Nucleic Acid 1Parainfluenza Multiplex Nucleic Acid Assay 1Respiratory Virus Panel Nucleic Acid Assay System 1Human Metapneumovirus (Hmpv) Rna Assay System 1Mycoplasma Pneumoniae Dna Assay System 1Bordetella Pertussis Dna Assay System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261475	BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit	2026-07-17
US	K243822	BioFire Warrior Panel; BioFire Warrior Panel Control Kit	2025-03-12
US	K213362	BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel	2023-03-22

BioFire Defense, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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