Sentosa SA vanA/vanB PCR Test

Primary DI

D-888501395SSAvanABT3Q

Basic UDI-DI Code

B-888501395SSAvanABT3Q

Reference

300015, 300016

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA vanA/vanB PCR Test is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test, for the qualitative detection and differentiation of vancomycin resistance (vanA and vanB) genes that can be associated with Vancomycin-Resistant Enterococcus (VRE). It detects vanA and vanB genotypes in rectal and / or perianal swab samples from patients at risk for nosocomial drug resistance infections, together with clinical and epidemiological risk factors. 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 vancomycin resistant colonization in healthcare settings. Negative results do not preclude VRE 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).