Multiple infectious organism IVDs

Intended purpose

Intended for in vitro diagnostic use to monitor the performance of in-vitro assays for determination of antibodies to Rubella, Cytomegalovirus, Herpes Simplex Virus Type 1 and 2, Toxoplasma gondii, Mumps, Measles, Varicella Zoster, Helicobacter pylori, Epstein-Barr Virus, Treponema pallidum and non-syphilitic antibodies (Syphilitic Reagin) in human serum and plasma. Positive controls will provide a positive reaction in assays that detect included analytes. Controls are unassayed without target ranges suitable for most analysers. For use in a clinical laboratory setting by trained personnel.