Sentosa SA Salmonella PCR Test (4x8)

Primary DI

08885013953022

Basic UDI-DI Code

B-08885013953022

Reference

300028

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Salmonella PCR Test is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test, for the qualitative detection of Salmonella enterica spp. obtained from stool specimens from patients. This in vitro diagnostic test is validated for use on the Sentosa® SX101 instrument, with 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 Salmonella enterica spp. infection. Negative results do not preclude Salmonella enterica spp. infection and should not be used as a sole basis for treatment and other patient management decisions.

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