Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 lynch syndrome test system
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
VENTANA MEDICAL SYSTEMS
  GRANTED 1

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1 1

-
-