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Summary Of Safety And Effectiveness Data (SSED).pdf

P210011B.pdf
Preview of Summary of Safety and Effectiveness Data (SSED)
🔗 Source: accessdata.fda.gov
📊 Size: 1.97 MB
👤 Author: CDRH QM
⬇️ Downloads: 66

Summary

The xT CDx is a Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for detecting substitutions, insertion and deletion alterations, and microsatellite instability (MSI) status in 648 genes using DNA from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens and matched normal blood or saliva specimens. It is a companion diagnostic to identify patients who may benefit from targeted therapies and provide tumor mutation profiling for previously diagnosed solid malignant neoplasms. The device has no known contraindications, and warnings and precautions are found in the labeling. The assay includes reagents, software, instruments, and procedures for testing DNA, with results categorized into three levels: CDx claims, cancer mutations with evidence of clinical significance, and cancer mutations with potential clinical significance.

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Description

The xT CDx is a Next Generation Sequencing (NGS)-based in vitro diagnostic device intended for detecting substitutions, insertion and deletion alterations, and...

Technical Information

  • File Format: PDF
  • File Size: 1.97 MB
  • Pages: 107
  • Language: EN
  • Author: CDRH QM
  • Total Downloads: 66
  • Last Updated: 7 days ago

Document Overview

This PDF document about Summary of Safety and Effectiveness Data (SSED) provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into Summary of Safety and Effectiveness Data (SSED).

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