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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device candida spp., direct antigen, id
Regulation Description Cryptococcus neoformansserological reagents.
Product CodeLRF
Regulation Number 866.3165
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1

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 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Lexamed III Mar-31-2009

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