PZJ · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 864.1866
Classification
FDA Product Code
PZJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.1866
Review panel
PA
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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