BEUDAMED
    5 results · 6ms · Sources: EU EUDAMED, US FDA

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

    CMV IgM EIA, in vitro diagnostic.

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022

    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

    FDA Enforcement
    Class II ·Ongoing·Rayner Intraocular Lenses Ltd·July 13, 2022

    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

    FDA Enforcement
    Class II ·Ongoing·Bio-Rad Laboratories, Inc.·May 25, 2022

    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·April 3, 2024

    HAMILTON-C6, REF: 160021

    FDA Enforcement
    Class II ·Ongoing·Hamilton Medical AG·May 3, 2023