Sentosa SA Norovirus RT-PCR Test v2.0 (4x24)

Primary DI

08885013953015

Basic UDI-DI Code

B-08885013953015

Reference

300202

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Norovirus RT-PCR Test v2.0 (4x24) is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test, for the qualitative detection and differentiation of RNA specific for Norovirus belonging to genogroup I (GI) and genogroup II (GII), in stool samples from patients with signs and symptoms of gastroenteritis. 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 (4x24), in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. The test results can be used as supplementary data for diagnosis, or large scale screening of Norovirus infection in case of an outbreak. Negative results do not preclude Norovirus infection and 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).