Sentosa SA NRAS PCR Test (4x8)

Primary DI

08885013953190

Basic UDI-DI Code

B-08885013953190

Reference

300086

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® NRAS PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the qualitative detection of mutations in codon 61 of NRAS gene from human patients with signs and symptoms of melanoma and thyroid cancer. This test is intended for use on the Sentosa® SX101 nucleic acid extraction platform with the QIAGEN Rotor-Gene® Q MDx 5plex HRM platform. Test results can be used as supplementary data for diagnosis, or large scale screening of the NRAS mutation. Negative results do not preclude an NRAS mutation and should not be used as a sole basis for treatment and other patient management decisions.

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