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

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

    Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation.

    FDA Enforcement
    Class III ·Terminated·Impact Instrumentation, Inc.·August 15, 2012

    Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: ¿ Cytomegalovirus (CMV) IgM ¿ Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM ¿ Rubella Virus IgM ¿ Toxoplasma gondii IgM

    FDA Enforcement
    Class III ·Terminated·Bio-rad Laboratories, Inc.·May 22, 2013