BEUDAMED
    10,000 results · 52ms · Sources: EU EUDAMED, US FDA

    Dimension EXL LOCI BRAHMS Procalcitonin (PCT)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIMENSION EXL WITH LM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

    FDA 510(k)
    FDA Class 2 ·Hematology

    Atellica® IM High-Sensitivity Troponin I (TnIH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

    FDA 510(k)
    FDA Class 2 ·Immunology

    Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica CH Phencyclidine (Pcp)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Emit® II Plus Buprenorphine Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Atellica CH Magnesium (Mg)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry