8 results
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7ms
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Sources: EU EUDAMED, US FDA
CMV IgM EIA, in vitro diagnostic.
FDA Enforcement
Class II
·Ongoing·Bio-Rad Laboratories, Inc.·December 7, 2022
HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114.
FDA Enforcement
Class II
·Ongoing·Hycor Biomedical LLC·November 6, 2019
Parvovirus B19 IgG EIA kit Part No. V519IGUS
FDA Enforcement
Class II
·Ongoing·Diasorin Inc.·September 9, 2020
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
FDA Enforcement
Class II
·Ongoing·Quidel Corporation·April 5, 2023
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
FDA Enforcement
Class II
·Ongoing·Hycor Biomedical Inc·August 14, 2019
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023