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Lynch Syndrome Test System

Lynch Syndrome Test System is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Lynch Syndrome Test System
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PZJ

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Class 2

21 CFR 864.1866

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Immunology

Device Characteristics

No

No

No

Not Eligible

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