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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 measles virus, mumps virus, rubella and varicella zoster virus
Regulation Description Rubella virus serological reagents.
Definition The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.
Product CodeOPL
Regulation Number 866.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
DYNEX TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1

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