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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, rna, staphylococcus aureus
Regulation Description Staphylococcus aureus serological reagents.
Definition The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).
Product CodeNXX
Regulation Number 866.3700
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 1 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-01-2014

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