BEUDAMED
    6 results · 14ms · 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

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    FDA Recall
    Completed ·International Science & Technology, LP, DBA Diamatrix Ltd.·Product code HNN·February 24, 2022

    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

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    FDA Enforcement
    Class II ·Completed·International Science & Technology, LP, DBA Diamatrix Ltd.·June 1, 2022

    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 Enforcement
    Class II ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 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