4 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
FDA Enforcement
Class III
·Terminated·Tripath Imaging, Inc.·June 27, 2012
VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·November 2, 2016
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
FDA Enforcement
Class III
·Terminated·Cook Medical Incorporated·April 13, 2022
Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;
FDA Enforcement
Class III
·Terminated·Cook Medical Incorporated·April 13, 2022