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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorbent assay, rubeola igm
Regulation Description Rubeola (measles) virus serological reagents.
Definition The qualitative detection of measles specific IgM antibodies in serum or plasma.
Product CodePCL
Regulation Number 866.3520
Device Class 1

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 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Clark Laboratories, Inc. (dba,Trinity Biotech USA) III Sep-12-2016

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