BEUDAMED
    26 results · 41ms · Sources: EU EUDAMED, US FDA

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    BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·May 13, 2026

    Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·May 13, 2026

    BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·June 4, 2025

    FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·April 16, 2025

    FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·September 18, 2024

    BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 28, 2024

    FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·September 18, 2024

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 14, 2024

    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·February 14, 2024

    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·February 14, 2024

    BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·December 13, 2023

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·January 17, 2024

    The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·January 17, 2024

    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 30, 2023

    FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels. Additional Part/Reference Numbers as part of the system: - HTFA-ASY-0102: BIOFIRE TORCH Duplex. This is a plastic component that covers the BIOFIRE TORCH Modules. The BIOFIRE TORCH Duplex is only necessary if the system includes more than two modules. - HFTA-SUB-0103: BIOFIRE TORCH Module. The BIOFIRE reagent pouches are inserted into the modules.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·November 29, 2023

    In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·March 22, 2023

    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·April 26, 2023

    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·March 22, 2023

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 30, 2023

    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·February 21, 2024