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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device elisa, antibody, west nile virus
Regulation Description West Nile virus serological reagents.
Definition The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.
Product CodeNOP
Regulation Number 866.3940
Device Class 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 0 1 0 0 0 0
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Focus Diagnostics Inc III Oct-31-2012
2 Inverness Medical II Feb-14-2012

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