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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device c.difficile toxin gene amplification assay
Definition Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
Product CodeOZN
Regulation Number 866.3130
Device Class 2


Premarket Reviews
ManufacturerDecision
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS 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 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Nanosphere, Inc. II Sep-23-2014
2 Nanosphere, Inc. III Aug-08-2014

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