PZJ

Lynch Syndrome Test System

Product code

PZJ

Device name

Lynch Syndrome Test System

Device class

Class 2

21 CFR

21 CFR 864.1866

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).