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

    IMMUCOR Medizinische Diagnostik GmbH

    Manufacturer
    🇩🇪 Germany·22 Basic UDI-DIs·73 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    IMMUCOR Medizinische Diagnostik GmbH

    Manufacturer
    🇩🇪 Germany·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Geratherm Medical GERMANY GmbH

    Manufacturer
    🇩🇪 Germany·20 Basic UDI-DIs·23 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    Gold Standard Diagnostics Kassel GmbH

    Manufacturer
    🇩🇪 Germany·572 Basic UDI-DIs·572 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    MACHEREY-NAGEL GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany·9 Basic UDI-DIs·14 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

    GILUPI GmbH

    Manufacturer
    🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    IMMUCOR Medizinische Diagnostik GmbH

    Manufacturer
    🇩🇪 Germany·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    KULZER GmbH

    Manufacturer
    🇩🇪 Germany·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    Ziehm Imaging GmbH

    Manufacturer
    🇩🇪 Germany·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    BESA GmbH

    Manufacturer
    🇩🇪 Germany·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    medentis medical GmbH

    Manufacturer
    🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    VitalAire GmbH

    Manufacturer
    🇩🇪 Germany·9 Basic UDI-DIs·9 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    RECA Med GmbH

    Manufacturer
    🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

    GME German Medical Engineering GmbH

    Manufacturer
    🇩🇪 Germany·6 Basic UDI-DIs·6 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH