Sentosa SA CMV Quantitative PCR Test (4x24)

Primary DI

08885013953275

Basic UDI-DI Code

B-08885013953275

Reference

300114

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA CMV Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection and quantitation of Cytomegalovirus (CMV) DNA using Sentosa® SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For human EDTA plasma, serum, urine 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 CMV Quantitative PCR Test is intended for use in the detection and quantitation of CMV DNA from symptomatic patients as an aid in CMV diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with CMV infection. The results from the Sentosa® SA CMV 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 Annex 2 List B) and regulation (EU IVDD).