BEUDAMED
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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872

    FDA Enforcement
    Class III ·Ongoing·Ortho-Clinical Diagnostics, Inc.·June 12, 2024

    Penner Pacific Bathing Spa, Model Numbers 360020-1EP

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026