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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis
Regulation Description Streptococcus spp. serological reagents.
Definition E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.
Product CodeOAH
Regulation Number 866.3740
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 1 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AdvanDx, Inc. II Aug-31-2010

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