Biocartis Idylla KRAS 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 Idylla™ KRAS Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic test for the qualitative detection of mutations in codons 12, 13, 59, 61, 117 or 146 of the KRAS oncogene. The Idylla™ KRAS Mutation Test, from sample to result, starts with formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer (CRC) tissue to liberate DNA for subsequent real-time PCR amplification and detection. The Idylla™ KRAS Mutation Test is intended to determine the tumor KRAS mutation status of patients with metastatic colorectal cancer at diagnosis and to facilitate treatment decisions within a multidisciplinary team. The Idylla™ KRAS Mutation Test is not intended to diagnose colorectal cancer.

leaflet_short:

Device System Info:[System or Procedure Pack], The Idylla™ System is an in vitro diagnostic (IVD) medical device, consisting of the Idylla™ Console and the Idylla™ Instrument(s). The System is intended for the detection of nucleic acid targets in various types of human samples.; Models: Idylla Instrument - P0010, Idylla Console - P1010, Idylla KRAS mutation test - A0020/6

תאריך אישור:

2017-11-24