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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-factor replacement product test system
Definition A non-factor replacement product test system is a prescription in vitro diagnostic device intended to measure non-factor replacement therapeutic products that are indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with bleeding disorders, including hemophilia, in human blood specimens to ensure appropriate therapy in accordance with the approved non-factor replacement product labeling.
Product CodeSES
Regulation Number 864.7298
Device Class 2


Premarket Reviews
ManufacturerDecision
RANDOX LABORATORIES LTD
  GRANTED 1

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