inforMED
PZJClass II

Lynch Syndrome Test System

Immunology · 21 CFR 864.1866

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

MDR events4All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances4All time

Recent MDR events

4 adverse event reports on file

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Event type breakdown

Malfunction3
Injury1

Most-reported manufacturers

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Ventana Medical Systems Inc.3Ventana Medical Systems1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

6 firms currently registered for this product code

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510(k) clearances

4 clearances for this product code

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