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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device nucleic acid amplification assay system, group b streptococcus, direct specimen test
Regulation Description Streptococcus spp. serological reagents.
Definition A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
Product CodeNJR
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
Cepheid
  SUBSTANTIALLY EQUIVALENT 3
MERIDIAN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 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 1 0 2 0 1 0
Class III 0 1 0 0 0 0 1 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. III Jul-03-2013
2 Becton Dickinson & Co. II Mar-22-2013
3 Becton Dickinson & Co. II Jan-22-2013
4 Biomerieux Inc II Dec-29-2015
5 Cepheid II May-31-2011
6 Cepheid III Jan-12-2008

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