Sentosa SA HHV6 Quantitative PCR Test

Primary DI

D-888501395SSAHHV6QTT4A

Basic UDI-DI Code

B-888501395SSAHHV6QTT4A

Reference

300157, 300184, 300180, 300673

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA HHV6 Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection and quantitation of Human Herpesvirus 6 (HHV6) DNA using Sentosa® SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For 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 HHV6 Quantitative PCR Test is intended for use in the detection and quantitation of HHV6 DNA from symptomatic patients as an aid in HHV6 diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with HHV6 infection. The results from the Sentosa® SA HHV6 Quantitative PCR Test 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).