Biocartis Idylla 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™ BRAF Mutation Test, performed on the Biocartis Idylla™ System, is an in vitro diagnostic Test for the qualitative detection of V600E/E2/D and V600K/R/M mutations in codon 600 of the BRAF gene. The Idylla™ BRAF Mutation Test uses DNA liberated from formalin-fixed paraffin-embedded (FFPE) tissue sections from human melanoma tumor cells. The Test is a sample-to-result real-time PCR. The results of the Idylla™ BRAF Mutation Test may be useful for the physician to aid in identifying metastatic melanoma patients who may benefit from BRAF targeted therapy. The Idylla™ BRAF Mutation Test is not intended to diagnose metastatic melanoma. The physician shall take other disease factors into account, other than the patient’s mutation status, to make a therapy decision.
Product summary:
Models: Idylla Instrument - P0010, Idylla Console - P1010, Idylla BRAF Mutation Test - A0010/6
Authorization number:
DE0019387
Authorization date:
2017-07-05

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