106 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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