Biocartis Idylla NRAS-BRAF Mutation Test

Singapore - English - HSA (Health Sciences Authority)

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Available from:
ANDAMAN MEDICAL PTE. LTD.
Class:
Class C IVD
Manufactured by:
Biocartis NV
Therapeutic area:
Pathology
Therapeutic indications:
The Idylla™ NRAS-BRAF 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, 146 of the NRAS gene and codon 600 of the BRAF gene. The Idylla™ NRAS-BRAF Mutation Test, from sample to result, starts with the liberation of DNA from formalin-fixed, paraffin-embedded (FFPE) human colorectal cancer tissue, followed by real-time PCR amplification and detection.
Product summary:
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)and Test specific Idylla™ Cartridges.; Models: Idylla Instrument - P0010, Idylla Console - P1010, Idylla NRAS-BRAF Mutation Test - A0030/6
Authorization number:
DE0501059
Authorization date:
2018-01-03

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