BEUDAMED
    230 results · 31ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    LYPHOCHEK DIABETES CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    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

    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

    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 HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCESS SPECIFIC IGE ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

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

    FDA 510(k)
    FDA Class 2 ·Hematology

    ACCESS(R) TOTAL T3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIOPLEX 2200 TORC IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ACCESS(R) THYROXINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCESS FERRITIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology