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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adamts13 activity test system
Definition An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings.
Product CodeSAC
Regulation Number 864.7297
Device Class 2


Premarket Reviews
ManufacturerDecision
TECHNOCLONE HERSTELLUNG VON DIAGNOSTIKA UND ARZNEIMITTELN GM
  GRANTED 1

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