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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme linked immunoabsorption assay, treponema pallidum
Regulation Description Treponema pallidumtreponemal test reagents.
Product CodeLIP
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 0 0 1 0
Class III 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories II Jun-11-2008
2 Bio-Rad Labroatories Inc. III Nov-09-2007
3 Siemens Healthcare Diagnostics, Inc II Aug-20-2012

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