BEUDAMED
    11 results · 62ms · Sources: EU EUDAMED, US FDA

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    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics

    FDA Enforcement
    Class II ·Ongoing·Helena Laboratories, Corp.·June 28, 2023

    V8 Immunodisplacement Kit REF 1803

    FDA Enforcement
    Class II ·Ongoing·Helena Laboratories, Corp.·June 15, 2022

    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Enforcement
    Class II ·Ongoing·Helena Laboratories, Corp.·July 17, 2019

    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    FDA Enforcement
    Class II ·Ongoing·Helena Laboratories, Corp.·July 17, 2019

    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·November 13, 2019

    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

    K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

    FDA Enforcement
    Class II ·Ongoing·Helena Laboratories, Corp.·December 23, 2020

    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