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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antibody igm, if, epstein-barr virus
Regulation Description Epstein-Barr virus serological reagents.
Product CodeLJN
Regulation Number 866.3235
Device Class 1


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1

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