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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device quality control for molecular immunohematology tests
Definition The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
Product CodePFK
Regulation Number 864.9650
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOARRAY SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROGENIKA BIOPHARMA, S.A.
  SUBSTANTIALLY EQUIVALENT 1

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