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bioMérieux submits Dual 510(k) and CLIA-waiver application to FDA for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel

bioMérieux, a world leader in the field of in vitro diagnostics, has submitted the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel to U.S. Food and Drug Administration (FDA) for a dual 510(k) clearance and CLIA1-waiver. This panel is already CE-marked (IVDD).

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Featured Products

BIOFIRE® FILMARRAY® Torch

For results that are fast and accurate, the BIOFIRE TORCH uses PCR technology to simultaneously test for a comprehensive grouping of targets in about an hour. For use in CLIA-moderate settings.

VITEK® MS

VITEK MS MALDI-TOF system helps laboratories deliver actionable results to clinicians to support informed treatment decisions.

VIDAS® B•R•A•H•M•S PCT™

PCT-guided antibiotic therapy. VIDAS B•R•A•H•M•S PCT aids physicians in making rational clinical decisions and allows optimized patient management. Results are available in only 20 minutes.

BACT/ALERT® VIRTUO®

VIRTUO Microbial Detection System, a fully automated blood culture solution with real-time notification of blood volume, quick time to detection, and virtually zero hands-on time.

BIOFIRE® Respiratory 2.1-EZ Panel (EUA)*

Perform in-clinic testing of those suspected of COVID-19. This syndromic panel identifies 19 probable bacterial and viral respiratory targets in one fast and easy test. *Emergency use authorization.

BIOFIRE® Joint Infection Panel

Overcome the challenges of traditional joint infection testing with a syndromic panel that identifies 31 pathogenic targets and 8 antimicrobial resistance genes—all onsite in CLIA-moderate settings. 

BIOFIRE® FILMARRAY® 2.0 EZ Configuration

The BIOFIRE 2.0 EZ facilitates fast, onsite respiratory testing. Designed to be used with the BIOFIRE RP2.1-EZ Panel (EUA)* in CLIA-waived settings, the system offers results in ~45 minutes.

BIOFIRE® FILMARRAY® Gastrointestinal Panel

Test for 22 gastrointestinal pathogens, including bacteria, yeast, and parasites, in one easy-to-perform test—with results in about an hour. Onsite in CLIA-moderate settings.

GENE-UP®

Our real-time PCR solution simplifies workflows, decreases cross-contamination risks, and gives you rapid results that speed up critical manufacturing decisions.

CONNECT-UP®

CONNECT-UP™  is our laboratory data management solution that simplifies workflow by connecting every step—from sample to decision. 

 

VERIFLOW™

VERIFLOW™ uses DNA Signature Capturing Technology to provide unmatched specificity and unrivaled sensitivity with zero compromises on ease-of-use in the production environment.

TEMPO®

TEMPO®  is a fully automated enumeration system that tests quality indicators in food products and environmental samples within your laboratory.

BACT/ALERT® 3D

From its ease of use to its flexible data management, the BACT/ALERT® 3D is a state-of-the art microbial detection system suitable for any size laboratory, providing you with a reliable and objective alternative to traditional microbial detection methods.

BIOFIRE® MYCOPLASMA

BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release.

3P® ENTERPRISE

By positioning an end-to-end and integrated solution with proven reading performances, bioMérieux allows healthcare industries to trust their data and empower their EM results to make decisions reliable and optimize the process efficiency.

VITEK® MS PRIME

The VITEK® MS PRIME is an innovative MALDI-TOF mass spectrometry system that takes your automated identification experience to the next level.

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Our purpose

WE HELP MAKE THE WORLD A HEALTHIER PLACE

This dedication to public health is the thread that connects everything we do. It connects us to our history - since 1963, we have been fulfilling the vision of the Mérieux family to improve health, while maintaining the values of respect, accountability, transparency, and sharing.