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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dna-reagents, neisseria
Regulation Description Neisseriaspp. direct serological test reagents.
Product CodeLSL
Regulation Number 866.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
BD
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 4
Cepheid
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIGENE CORP.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
Break 1
Improper or incorrect procedure or method 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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