BEUDAMED
    462 results · 72ms · Sources: EU EUDAMED, US FDA
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    BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioPlex 2200 25-OH Vitamin D Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUICHEK TORCH PLUS IGM CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCESS PROLACTIN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESS RUBELLA IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCESS PROLACTIN ASSAY (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ACCESS SPECIFIC IGE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS ULTRASENSITIVE INSULIN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0

    FDA 510(k)
    FDA Class 2 ·Hematology