4 results
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6ms
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Sources: EU EUDAMED, US FDA
MAS Omni Immune Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
MAS Omni Immune PRO Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
FDA Enforcement
Class III
·Terminated·Thermofisher Scientive·December 4, 2013
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