BEUDAMED
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    LQC Cardiac Control CS, mini pack

    FDA UDI
    CLINIQA CORPORATION·00817238011520·LQC Cardiac Control CS, mini pack

    LQC Cardiac Control CS, Tri-level kit

    FDA UDI
    CLINIQA CORPORATION·00817238011513·LQC Cardiac Control CS, Tri-level kit

    DAU LOW QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAULQCFSH0·DAU LOW QC

    DRUGS OF ABUSE LOW

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAULQCV3UK0·DRUGS OF ABUSE LOW

    DAU LOW

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAUV2LQCSH0·DAU LOW

    DAU LOW QC

    FDA UDI
    UTAK LABORATORIES, INC.·B800DAULQCV3FUHCMC0·DAU LOW QC

    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Enforcement
    Class III ·Terminated·LumiraDx·November 2, 2022

    AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ITREVIA 5 DR-T DF4 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·July 13, 2021

    ACT-LR CUVETTE ASSAY

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORPORATION·Product code JBP·October 22, 2013

    INLEXA 3 VR-T DF4 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·May 25, 2021

    IFORIA 5 VR-T DX PROMRI DF-1

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·June 4, 2021

    INTICA 5 HF-T QP DF4 IS4 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NIK·June 17, 2021

    IFORIA 3 VR-T DF4

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·June 2, 2021

    IFORIA 5 DR-T PROMRI DF-1

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·May 28, 2021

    ITREVIA 5 HF-T QP DF4 IS4 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NIK·May 19, 2021

    IFORIA 3 HF-T DF-1

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NIK·June 2, 2021

    ITREVIA 5 VR-T DF4 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·June 2, 2021

    ITREVIA 5 DR-T DF4 PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·June 23, 2021

    IFORIA 5 DR-T PROMRI DF4

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code MRM·May 25, 2021