Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24)

Primary DI

08885013953107

Basic UDI-DI Code

B-08885013953107

Reference

300145

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Influenza A/B & RSV RT-PCR Test (4x24) is a fourplex, real-time PCR based in vitro diagnostic test. This test is intended for the qualitative detection of influenza A, influenza B and / or respiratory syncytial virus (RSV) nucleic acids obtained from clinical specimens (nasal swabs or nasopharyngeal swabs) from patients with signs and symptoms of respiratory tract infections. The targets in the PCR are the matrix protein genes from the influenza virus or the M gene from RSV. 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. Negative results do not preclude influenza or RSV infection and should not be used as a sole basis for treatment or other patient management decisions. Mutations that arise within the highly conserved regions of the viral genome covered by the kit’s primers and / or probes may result in failure to detect the presence of the virus. The product is to be used by personnel trained in in vitro diagnostic procedures. Detection of viral RNA depends on the number of viruses present in the sample, and can be affected by sample collection methods, patient-related factors (e.g., age, symptoms), or infection stage and sample size.

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