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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assayed external control material for microbiology nucleic acid amplification (nat) assays for blood donor screening.
Regulation Description Assayed quality control material for clinical microbiology assays.
Definition Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use for blood donor screening.
Product CodeQTM
Regulation Number 866.3920
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 2
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2

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