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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device multiplex immunoassay for t. gondii, rubella, cytomegalovirus and herpes simplex virus 1 and 2
Regulation Description Rubella virus serological reagents.
Definition The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not intended for use in screening blood or plasma donors.
Product CodeOPM
Regulation Number 866.3510
Device Class 2