BEUDAMED
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    VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·October 8, 2025

    VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·September 7, 2022

    VIDAS DEX@, Dimer Exclusion II, REF 30455-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Mumps IgG (MPG), REF 30218

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·August 31, 2022

    VIDAS SARS-COV-2 IgM, Ref 423833-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Lyme IgM II (LYM), REF 416436

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS RUB IgG (RBG), REF 30226

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Measles IgG (MSG), REF 30219

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS SARS-COV-2 IgG, Ref 423834-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS FSH, REF 30407-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Estradiol II, REF 30431-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS PRG Progesterone, REF 30409-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS LH, REF 30406-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Clostridium Difficile GDH, REF 30125-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    VIDAS Lyme IgG II (LYM), REF 417401

    FDA Enforcement
    Class II ·Ongoing·bioMerieux, Inc.·January 5, 2022

    The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

    FDA Enforcement
    Class II ·Ongoing·Biomerieux Inc·April 29, 2020