Sentosa SA Dengue I-IV RT-PCR Test (4x8)

Primary DI

08885013953121

Basic UDI-DI Code

B-08885013953121

Reference

300050

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Dengue I-IV RT-PCR Test is a duplex, real-time PCR based in vitro diagnostic test. This test is intended for rapid in vitro qualitative detection of the 3’ un-translated region (3’UTR) in all four dengue serotypes, in clinical samples (serum / EDTA plasma) obtained from patients. This in vitro diagnostic test is configured for use on the Sentosa® SX101 instrument, with Sentosa® SX Virus Total Nucleic Acid Kit v2.0, in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument.

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