Business Wire

BioFire Submits Special 510(k) Application to the FDA for the use of FilmArray ® Torch, the New High Throughput FilmArray ® System with FilmArray ® Respiratory Panel

MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular ...
FierceBiotech

BioFire Diagnostics wins FDA clearance for innovative GI panel

BioFire Diagnostics won 510(k) clearance for its gastrointestinal panel for infectious diarrhea, following in the footsteps of the company's acquisition by French diagnostic giant bioMérieux.
FierceBiotech

BioMérieux's BioFire sets course for GI panel FDA clearance

Just a month out from being bought by French giant bioMérieux, BioFire Diagnostics took its FilmArray diagnostic system's new gastrointestinal option to the FDA for clearance, which the newly united ...
Nasdaq

bioMérieux: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

MARCY L’ÉTOILE, France--(BUSINESS WIRE)-- Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary ...
Business Wire

bioMérieux submits for FDA Clearance of the BIOFIRE ® FILMARRAY ® Pneumonia Panel

MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology ...
Yahoo Finance

bioMérieux Receives Health Canada Approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel

MONTREAL, Feb. 25, 2025 /CNW/ - bioMérieux, a world leader in the field of in vitro diagnostics, has achieved a significant milestone with the Health Canada approval of the BIOFIRE ® SPOTFIRE ® ...
Nasdaq

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

MARCY L’ÉTOILE, France--(BUSINESS WIRE)-- Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology ...
Yahoo Finance

Net Medical Announces Availability of BIOFIRE(R) Joint Infection Tests

ALBUQUERQUE, NM / ACCESSWIRE / August 8, 2022 / Net Medical (OTC Pink:NMXS) announced today it has begun offering biomerieux's new BIOFIRE® Joint Infection (JI) panel to support orthopedic surgeons in ...
Healio

BioFire Global Fever Panel successfully detects common acute fever-causing pathogens

Please provide your email address to receive an email when new articles are posted on . A 1-hour sample-to-answer, molecular device successfully detected common causative pathogens of acute febrile ...
technologynetworks

BioFire Dx Initiates Clinical Study for the FilmArray™ Meningitis/Encephalitis Panel

Infection of the meninges surrounding the brain and spinal cord (meningitis), or of the brain (encephalitis) can have high mortality and morbidity rates depending on the source of infection. Acute ...
KSL

Utah biotech firm BioFire earns first full FDA COVID-19 test approval

This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in ...