BEUDAMED
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    PQ1

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Atellica IM High-Sensitivity Troponin I (TNIH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Enhanced Liver Fibrosis (ELF)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur High-Sensitivity Troponin I (TNIH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA CENTAUR TESTOSTERONE (TSTO)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MDI MII ONE-PIECE IMPLANT, 2.9MM

    FDA 510(k)
    FDA Class 2 ·Dental

    CLINICAL ALERT NOTIFICATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA Centaur TSH3-Ultra

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PATIENT EXAMINATION GLOVEWS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVIA CENTAUR FT4, ADVIA CENTAUR T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Toxoplasma M (Toxo M)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES

    Device
    EU MDR · Eu Md Class 2b ·GASIN II, Gases Industriais, Unipessoal, Lda·On the market·1 country

    REF SOLN

    FDA UDI
    RANDOX LABORATORIES LIMITED·05055273214338·This is required for measuring reference electr...

    Ready Sensor™ GOLD Reference Sensor Inner Element

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414115030·Ready Sensor™ GOLD Replacement reference Sensor...

    ANTI-GST PI

    FDA UDI
    BIOGENEX LABORATORIES·00810119679048·

    Pointe Scientific, Inc.

    FDA UDI
    POINTE SCIENTIFIC, INC.·00811727012838·ISE Internal Reference, for the quantitative de...

    Potassium Electrode

    FDA UDI
    Roche Diagnostics GmbH·04015630918737·