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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lynch syndrome test system
Regulation Description Lynch syndrome test systems.
Definition The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome
Product CodePZJ
Regulation Number 864.1866
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOCARTIS NV
  SUBSTANTIALLY EQUIVALENT 1
LEICA BIOSYSTEMS NEWCASTLE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMEGA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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