BEUDAMED
    21 results · 36ms · Sources: EU EUDAMED, US FDA

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    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

    FDA Enforcement
    Class II ·Ongoing·Abbott GmbH·April 10, 2024

    Alinity i Anti-HCV Reagent Kit, List Number 08P0521

    FDA Enforcement
    Class II ·Ongoing·Abbott GmbH·April 10, 2024

    ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·May 16, 2018

    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c processing module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 24, 2019

    Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·February 6, 2019

    Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 24, 2019

    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 5, 2019

    Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·September 4, 2019

    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 12, 2019

    Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·June 3, 2020

    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·December 4, 2019

    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada

    FDA Enforcement
    Class II ·Terminated·Abbott GmBH & Co. KG·December 4, 2019

    Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 1, 2020

    Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution

    FDA Enforcement
    Class II ·Ongoing·Abbott Gmbh & Co. KG·December 4, 2019

    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·April 29, 2020

    Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·August 5, 2020

    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 24, 2020

    The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·August 14, 2019