• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device next generation sequencing based tumor profiling test
Regulation Description 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
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

-
-