BEUDAMED
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    Epitope Diagnostics, Inc.

    Manufacturer
    🇺🇸 United States·1 Importer

    EPITOPE DIAGNOSTICS, INC.

    FDA registration
    EPITOPE DIAGNOSTICS, INC.·77 products·🇺🇸 United States

    EDI™ CARE™

    FDA UDI
    EPITOPE DIAGNOSTICS INC·00893230002032·Fecal Occult Blood Test

    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

    FDA Recall
    Open, Classified ·Epitope Diagnostics, Inc.·Product code QKO·October 1, 2020

    IBERLAB - SOLUÇÕES PARA LABORATÓRIOS, LDA

    Importer
    🇵🇹 Portugal·3 Manufacturers

    EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.

    FDA Enforcement
    Class II ·Ongoing·Epitope Diagnostics, Inc.·November 18, 2020

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices