BEUDAMED
    25 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Enforcement
    Class II ·Ongoing·Biocartis Nv·January 22, 2025

    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

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

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

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·September 20, 2023

    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

    FDA Enforcement
    Class II ·Ongoing·Hologic Inc·October 2, 2024

    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

    BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

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

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

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

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

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

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

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

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

    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

    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

    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

    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

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·February 7, 2024

    FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.

    FDA Enforcement
    Class II ·Ongoing·Biofire Defense·October 1, 2025