BEUDAMED
    70 results · 8ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii ×

    Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 18, 2014

    Ringed DxI Reaction Vessels (RVs)

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 2, 2023

    DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·October 18, 2023

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 21, 2024

    DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·July 10, 2024

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·February 26, 2014

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·April 30, 2025

    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·February 14, 2024

    UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 29, 2012

    DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 28, 2012

    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 28, 2012

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 26, 2025

    UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 29, 2012

    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 28, 2012

    DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·September 11, 2024

    Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number A16972, for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·December 18, 2024

    Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·June 10, 2020