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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device epstein-barr virus, other
Product CodeLSE
Regulation Number 866.3235
Device Class 1


Premarket Reviews
ManufacturerDecision
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 2
QUEST INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Incorrect Control/Treatment Settings 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories II Apr-27-2011
2 Calbiotech Inc II Mar-05-2010
3 Diamedix Corporation II May-16-2016
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