BEUDAMED
    106 results · 15ms · 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 × Regulation: Us FDA × 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

    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

    cobas e801 Immunoassay Analyzer

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·August 17, 2022

    VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.

    FDA Enforcement
    Class II ·Ongoing·ORTHO-CLINICAL DIAGNOSTICS·January 9, 2019

    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

    Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

    FDA Enforcement
    Class II ·Ongoing·TECHNO-PATH MANUFACTURING LTD.·November 19, 2025

    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