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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device next generation sequencing based tumor profiling test
Definition A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.
Product CodePZM
Regulation Number 866.6080
Device Class 2


Premarket Reviews
ManufacturerDecision
ACT GENOMICS
  SUBSTANTIALLY EQUIVALENT 1
MEMORIAL SLOAN-KETTERING CANCER CENTER
  GRANTED 1
NANTHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
NYU LANGONE MEDICAL CENTER
  SUBSTANTIALLY EQUIVALENT 1
PERSONAL GENOME DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

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