BEUDAMED
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    DxA 5000, DxA 5000 Fit

    Device
    EU IVDR · Eu Ivd Class A ·Beckman Coulter Biomedical GmbH·On the market·32 countries

    DxA Automation System

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·Beckman Coulter Biomedical GmbH·5 devices

    DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Biomedical GmbH·July 26, 2023

    Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Biomedical GmbH·July 26, 2023

    DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Biomedical GmbH·September 30, 2020