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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antigen, iha, cytomegalovirus
Regulation Description Cytomegalovirus serological reagents.
Product CodeLJO
Regulation Number 866.3175
Device Class 2


Premarket Reviews
ManufacturerDecision
DIGENE CORP.
  SUBSTANTIALLY EQUIVALENT 1
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1

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