Sentosa SA RSV RT-PCR Test

Primary DI

08885013953978

Basic UDI-DI Code

B-08885013953978

Reference

111326

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa SA RSV RT-PCR Test is a real-time PCR-based in vitro diagnostic test for the qualitative detection of Respiratory Syncytial Virus (RSV). It detects both subtypes A and B of RSV in nasal and nasopharyngeal swab samples from human patients with signs and symptoms of respiratory tract infections This diagnostic test kit is configured for use with the Sentosa SX101 nucleic acid extraction platform, with the Sentosa SX Virus Total Nucleic Acid Kit, in conjunction with the Rotor-Gene Q MDX 5plex HRM system. Test results can be used as supplementary data for diagnosis, or large scale screening of RSV infection in cases of a flu outbreak. Negative results do not preclude RSV 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).