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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurologic disease risk assessment molecular test
Definition A neurologic disease predisposition risk assessment system is a prescription in vitro diagnostic device intended to detect or measure DNA, RNA, or protein variants in human specimens. The measurements aid in the evaluation of the risk of developing a neurologic disease in patients presenting with symptoms and/or with disease-associated risk factors to aid in patient management, in conjunction with other laboratory and clinical information.
Product CodeSFC
Regulation Number 866.5850
Device Class 2


Premarket Reviews
ManufacturerDecision
FIRALIS SA
  GRANTED 1

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