Sentosa SA BRAF V600 PCR Test (4x8)

Primary DI

08885013953176

Basic UDI-DI Code

B-08885013953176

Reference

300003

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA BRAF V600 PCR Test (4x8) is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test for the qualitative detection of mutations in the BRAF gene. It detects both V600E and V600K mutations in formalin-fixed, paraffin-embedded (FFPE) samples from patients with signs and symptoms of melanoma. This in vitro diagnostic test is configured for use with the Sentosa® SX101 instrument, with the Sentosa® SX FFPE gDNA Kit (4x8), in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. The test results can be used as supplementary data for diagnosis. Negative results should not be used as a sole basis for treatment and other patient management decisions.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).