bioMérieux, Inc.

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Fast, comprehensive onsite infectious disease testing.

About bioMérieux | Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for more than 55 years, bioMérieux provides diagnostic solutions (systems, reagents, software) that determine the source of disease and contamination to improve patient health and ensure consumer safety. The company’s products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical, and cosmetic products. Fast and actionable diagnostics are essential in fighting significant issues like antibiotic resistance, food borne illness, and sepsis.

Products

BIOFIRE® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)

The BIOFIRE RP2.1-EZ Panel (EUA) enables in-clinic testing of those suspected of COVID-19. This syndromic panel identifies 19 respiratory targets—including SARS-CoV-2—in one test with results in about 45 minutes.... More Info Less Info

The BIOFIRE RP2.1-EZ Panel (EUA) is designed to run on the BIOFIRE 2.0 EZ configuration system in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Product not available outside U.S.

*This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel

The syndromic BIOFIRE GI Panel tests for 22 of the most common pathogens associated with gastroenteritis, including bacteria, viruses, and parasites, with results available in about one hour.... More Info Less Info

Gastroenteritis can be caused by many enteric pathogens that cause similar, overlapping symptoms. Unfortunately, traditional stool testing and send-out methods are slow and may not offer clear answers, leaving clinicians to make treatment decisions without reliable results. Syndromic testing with the BIOFIRE GI Panel provides comprehensive answers fast—directly onsite—giving clinicians the information they need to make timely and informed treatment decisions. The BIOFIRE GI Panel is intended to be run in a CLIA-moderate setting on the BIOFIRE TORCH and BIOFIRE® FILMARRAY® 2.0 Systems.

BIOFIRE® Joint Infection (JI) Panel

The BIOFIRE JI Panel tests for 39 targets commonly associated with joint infections, including gram-positive and gram-negative bacteria, yeast, and antimicrobial resistance genes, with results in about an hour.... More Info Less Info

Traditional testing for joint infections is complex, often requiring multiple patient samples, various send-out tests, and days of waiting for results. The BIOFIRE JI Panel is a rapid syndromic test that delivers comprehensive results in one easy-to-read report. Using PCR technology, the BIOFIRE JI Panel offers a rapid sample-to-answer turnaround without sacrificing performance. Get results on 39 clinically relevant targets with just one syndromic test, a 0.2 mL sample of synovial fluid, and about an hour. The BIOFIRE JI Panel is intended to be run in a CLIA-moderate setting on the BIOFIRE TORCH and BIOFIRE 2.0 Systems.

BIOFIRE® FILMARRAY® 2.0 EZ Configuration System

The BIOFIRE 2.0 EZ Configuration facilitates rapid, near-patient molecular diagnostic testing. It is designed to be used with the BIOFIRE® RP2.1-EZ Panel (EUA) in CLIA-waived testing sites, including clinics and physician offices.... More Info Less Info

With integrated sample preparation, amplification, detection, and analysis, the BIOFIRE 2.0 EZ uses multiplex PCR technology to simultaneously test for a comprehensive grouping of targets in about 45 minutes. The BIOIRE 2.0 EZ requires just two minutes of hands-on time. Product not available outside U.S.

BIOFIRE® FILMARRAY® TORCH

The high-throughput BIOFIRE TORCH is a fully integrated, random-access system intended for use in CLIA-moderate settings. It can run 6 FDA-cleared BIOFIRE® FILMARRAY® Panels, including the BIOFIRE GI Panel and the BIOFIRE JI Panel.... More Info Less Info

With integrated sample preparation, amplification, detection, and analysis, the BIOFIRE TORCH uses multiplex PCR technology to simultaneously test for a comprehensive grouping of targets in about an hour. The BIOFIRE TORCH is scalable and provides quick, comprehensive, and accurate results. Its simplified workflow features a touchscreen interface and integrated barcode scanner. Data management automation includes LIS connectivity and random-access operation.

bioMérieux, Inc.

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