BEUDAMED
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    Filters FDA Enforcement × Status: Terminated × Clear all

    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014

    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP system.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014

    ADVIA Centaur¿ HBc IgM

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    EPIDURAL CATHETERIZATION KIT, Product Code BJC-05400-BEN

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·February 19, 2020

    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics, Inc.·November 24, 2021

    IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 CEA

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 TG

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018