BEUDAMED
    2 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii × Status: Ongoing × Clear all

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    FDA Enforcement
    Class III ·Ongoing·AMS Diagnostics, LLC·July 19, 2017

    OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

    FDA Enforcement
    Class III ·Ongoing·POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC·November 26, 2025