BEUDAMED
    2 results · 125ms · Sources: EU EUDAMED, US FDA

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    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code CGA·August 16, 2022