Device Recall Oncomine Dx Target Test


  • Dirección del fabricante
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • Empresa matriz del fabricante (2017)
  • Source

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  • Modelo / Serial
    Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017)  UDI: (01)10190302006071
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US Distribution to the states of: AZ, CA, NC, TX, and VA.
  • Descripción del producto
    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 || The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
  • Manufacturer