Sentosa SA HSV1/2 PCR Test (4x24)

Primary DI

D-888501395SSAHSV12QLTV8

Basic UDI-DI Code

B-888501395SSAHSV12QLTV8

Reference

300064

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA HSV1/2 PCR Test (4x24) is a multiplex, real-time PCR-based in vitro diagnostic test intended for use in the detection and differentiation of Herpes Simplex Virus 1&2 (HSV1/2) DNA in genital or oral swabs in UTM, EDTA plasma, serum and cerebrospinal fluid (CSF) from patients with signs and symptoms of HSV infections. This in vitro diagnostic test is validated to be performed on the automated Sentosa® SX101 instrument, using the Sentosa® SX Virus Total Nucleic Acid Kit v2.0 (4x24), in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument.

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