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Lynch Syndrome Test System

FDA product code PZJ · 3 cleared devices

Class 2 Immunology
Regulation
21 CFR 864.1866
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-07-26 – 2023-02-27

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

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