BEUDAMED
    5 results · 50ms · Sources: EU EUDAMED, US FDA

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

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code QJR·September 23, 2021

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

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code QJR·January 30, 2023

    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OOI·November 19, 2021

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

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OCC·January 30, 2023

    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 Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OOI·June 14, 2023