Sentosa SA BKV PCR Test (4X48)

Primary DI

08885013953749

Basic UDI-DI Code

B-08885013953749

Reference

300636

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA BKV Quantitative PCR Test is a real-time PCR-based in vitro diagnostic test intended for use in the detection and quantitation of BK virus (BKV) DNA using Sentosa® SX101 instrument in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. For human EDTA plasma, serum and urine 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 BKV Quantitative PCR Test is intended for use in the detection and quantitation of BKV DNA from symptomatic patients as an aid in BKV diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with BKV infection. The results from the Sentosa® SA BKV Quantitative PCR Test must be interpreted within the context of all relevant clinical and laboratory findings.

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