7 results
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7ms
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Sources: EU EUDAMED, US FDA
Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·November 28, 2012
VITROS Immunodiagnostic Products TSH Reagent Pack
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Systems·April 18, 2018
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc·November 13, 2013
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
FDA Enforcement
Class III
·Terminated·Randox Laboratories, Limited·November 20, 2019
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
FDA Enforcement
Class III
·Terminated·ROi CPS LLC·April 6, 2022
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Enforcement
Class III
·Terminated·LumiraDx·November 2, 2022
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