BEUDAMED
    3 results · 18ms · Sources: EU EUDAMED, US FDA

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

    SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Corp.·October 16, 2019

    Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Corp.·October 9, 2019

    Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Corp.·February 17, 2021