Somatic gene mutation detection system

FDA product code OWD · Class 3 · 4 devices · 133 reports · 1 devices named in recalls

• cobas® EGFR Mutation Test v2 2.0

  Roche Molecular Systems, Inc. · Somatic gene mutation detection system
  129 reports
• therascreen® KRAS RGQ PCR Kit 1

  QIAGEN GmbH · Somatic Gene Mutation Detection System
  2 recalls0 reports
• RealTime 08N90-090

  Abbott Molecular Inc. · Somatic gene mutation detection system
  2 reports
• therascreen® EGFR RGQ PCR Kit 1

  QIAGEN GmbH · Somatic Gene Mutation Detection System
  2 reports