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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reagent, borrelia serological reagent
Regulation Description Treponema pallidum treponemal test reagents.
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
WAMPOLE LABORATORIES,LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
False negative result 8
Incorrect or inadequate result 5
False positive result 2
Device displays error message 1
Therapeutic or diagnostic output failure 1
Total Device Problems 17

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 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Innominata Dba Genbio II Mar-08-2013

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