BEUDAMED
    5 results · 16ms · Sources: EU EUDAMED, US FDA

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

    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

    FDA Enforcement
    Class II ·Ongoing·DiaSorin Molecular LLC·March 15, 2023

    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

    FDA Enforcement
    Class II ·Ongoing·DiaSorin Molecular LLC·March 15, 2023

    SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

    FDA Enforcement
    Class II ·Ongoing·DiaSorin Molecular LLC·October 27, 2021

    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

    FDA Enforcement
    Class II ·Ongoing·DiaSorin Molecular LLC·January 12, 2022

    Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452

    FDA Enforcement
    Class II ·Ongoing·DiaSorin Molecular LLC·July 26, 2023