Sentosa SA Rotavirus RT-PCR Test (4x24)

Primary DI

08885013953039

Basic UDI-DI Code

B-08885013953039

Reference

300192

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Rotavirus 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 Rotavirus nucleic acids obtained from clinical stool specimens from patients with signs and symptoms of diarrhea. This test targets NSP4 gene of Rotavirus A. This in vitro diagnostic test is configured for use on the Sentosa® SX101 instrument, with the 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).