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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device multiplex flow immunoassay, t.gondii, rubella and cmv.
Regulation Description Rubella virus serological reagents.
Definition The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Product CodeOMI
Regulation Number 866.3510
Device Class 2

Device Problems
False positive result 2
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011

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