BEUDAMED
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    TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVE PSA IRMA (DSL-9700)

    FDA 510(k)
    FDA Class 2 ·Immunology

    STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRIAGE BNP TEST, MODEL 98000XR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ELECSYS PSA, MODEL # ELECSYS 1010

    FDA 510(k)
    FDA Class 2 ·Immunology

    ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    TPSA FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    Alere NT-proBNP for Alinity i Reagent Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PATHFAST NTPROBNP AND D-DIMER TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROSTATE SPECIFIC ANTIGEN METHOD

    FDA 510(k)
    FDA Class 2 ·Immunology

    COMPLEXED PSA MICROTITER ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys proBNP II, Elecsys proBNP II STAT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry