Device type
Lynch Syndrome Test System
Product code PZJ · Class II · 21 CFR 864.1866 · Immunology
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
Recent 510(k)s
Oct 23, 2026
K260776
VENTANA MMR IHC Panel
Roche Tissue Diagnostics, Inc.
- PZJ
- Class II
Recent recalls
No recalls in the archive for PZJ.