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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antigen, ha (including ha control), rubella
Regulation Description Rubella virus serological reagents.
Product CodeGOL
Regulation Number 866.3510
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Calibration error 30
Device displays error message 30
Total Device Problems 60

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