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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antigen, cf (including cf controls), respiratory syncytial virus
Regulation Description Respiratory syncytial virus serological reagents.
Product CodeGQG
Regulation Number 866.3480
Device Class 1


Premarket Reviews
ManufacturerDecision
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1


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