BEUDAMED
    2 results · 14ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Iii ×

    Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.

    FDA Enforcement
    Class III ·Ongoing·Beckman Coulter, Inc.·October 23, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Enforcement
    Class III ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022