Sentosa SA VZV PCR Test (4x24)

Primary DI

08885013953350

Basic UDI-DI Code

B-08885013953350

Reference

300081

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA VZV Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection and quantitation of Varicella-Zoster virus (VZV) DNA using Sentosa® SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For swab in UTM, human EDTA plasma, serum and cerebrospinal fluid (CSF) samples, Sentosa® SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for DNA extraction; and for human EDTA whole blood samples, Sentosa® SX Whole Blood Kit (4x24) is used for DNA extraction. The Sentosa® SA VZV Quantitative PCR Test is intended for use in the detection and quantitation of VZV DNA from symptomatic patients as an aid in VZV diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with VZV infection. The results from the Sentosa® SA VZV Quantitative PCR Test (4x24) must be interpreted within the context of all relevant clinical and laboratory findings.

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