Biocartis Idylla EGFR Mutation Test

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

זמין מ:

ANDAMAN MEDICAL PTE. LTD.

סיווג:

Class C IVD

תוצרת:

Biocartis NV

איזור תרפויטי:

Pathology

סממני תרפויטית:

The Biocartis Idylla™ EGFR Mutation Test performed on the Biocartis Idylla™ System, is an in vitro diagnostic test intended for the qualitative detection of exon 18 (G719A/S/C), exon 21 (L858R, L861Q), exon 20 (T790M, S768I) mutations, exon 19 deletions and exon 20 insertions in the EGFR oncogene. The Idylla™ EGFR Mutation Test uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human non-small cell lung cancer (NSCLC) tissue. The Idylla™ EGFR Mutation Test covers the entire process from FFPE sample to result, including fully integrated sample preparation, liberation of nucleic acids, real-time PCR amplification and detection, and data analysis.

leaflet_short:

Device System Info:[System or Procedure Pack], The Idylla™ System is an IVD medical device, consisting of Idylla™ Console and Idylla™ Instrument(s). It is intended for the detection of nucleic acid targets in various types of human samples, using disposable Test specific Idylla™ Cartridges.; Models: Idylla Instrument - P0010, Idylla Console - P1010, Idylla EGFR Mutation Test - A0060/6

תאריך אישור:

2018-07-09