Sentosa SA Strep A PCR Test (4x8)

Primary DI

08885013953091

Basic UDI-DI Code

B-08885013953091

Reference

300032

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Strep A PCR Test is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test, for the qualitative detection of Group A Streptococcus (Streptococcus pyogenes) in throat and wound swab samples. This in vitro diagnostic test is validated for use on the Sentosa® SX101 instrument, with the Sentosa® SX Bacteria gDNA Kit v2.0, in conjunction with the Rotor-Gene® Q MDx 5plex HRM instrument. The test results can be used as supplementary data for diagnosis, or large scale screening of Group A Streptococcal infection. Negative results do not preclude Group A Streptococcal infection and should not be used as a sole basis for treatment and other patient management decisions.

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