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Biofire Diagnostics, Inc.

USA · Salt Lake City

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

22listed device types

Class I 0Class II 22Class III 0

plus 26 registration records and 37 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

11 including historic records

TWTaiwanTFDA

11valid device licences

Class II 9Class III 2

SGSingaporeHSA SMDR

12device registrations

CLASS C 9CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 3IVD Class 3 1

HKHong KongMDACS

10valid listings

IVD C 10

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 2Class 2b 3Class 3 2

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 States26 registration records, 37 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: BioFire Diagnostics, LLC · BIOFIRE DIAGNOSTICS, LLC. · BIOFIRE DIAGNOSTICS LLC

FDA 510(k) clearances by year

52013

12014

52015

52016

22017

32018

12020

22021

22022

32023

62024

22025

FDA listed device types

showing 8 of 22

Gram-Positive Bacteria And Their Resistance Markers 1Bordetella Pertussis Dna Assay System 1Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System 1Chlamydophila Pneumoniae Dna Assay System 1Parainfluenza Multiplex Nucleic Acid Assay 1Respiratory Virus Panel Nucleic Acid Assay System 1Human Metapneumovirus (Hmpv) Rna Assay System 1Respiratory Panel 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243544	BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini	2025-08-14
US	K243885	BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid	2025-01-16
US	K243759	BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))	2024-12-20
BR	10158120704	Biofire FilmArray 2.0	Class II
BR	10158120712	Biofire FilmArray Torch	Class II
BR	10158120749	BioFire® SpotFire®	Class II