QuidelOrtho Receives FDA 510(okay) Clearance for VITROS® Syphilis Assay – The Journal of Healthcare Contracting

QuidelOrtho Receives FDA 510(okay) Clearance for VITROS® Syphilis Assay – The Journal of Healthcare Contracting



August 30, 2024 – QuidelOrtho Company has acquired U.S. Meals and Drug Administration (“FDA”) 510(okay) clearance for its VITROS syphilis check as a part of its menu, additional strengthening QuidelOrtho’s place as a frontrunner in infectious illness testing. This check is meant for the qualitative willpower of complete (IgG and IgM) antibodies to Treponema pallidum (TP)-specific antigens in human serum and plasma utilizing the automated VITROS 3600, 5600, and XT 7600 techniques.

The presence of antibodies to TP-specific antigens, together with non-treponemal laboratory testing and medical findings, can support within the analysis of syphilis an infection. The VITROS syphilis check shouldn’t be meant for screening blood and tissue donors. With the addition of the U.S., the VITROS syphilis check is now out there globally wherever QuidelOrtho merchandise can be found. This enlargement into the U.S. market is concentrated on offering well timed and correct analysis, vital for efficient remedy and management of the illness.

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