Sentosa SA Direct MRSA/SA PCR Test (4x24)

Primary DI

08885013953077

Basic UDI-DI Code

B-08885013953077

Reference

300247

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA Direct MRSA/SA PCR Test (4x24) is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test for the qualitative detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from nasal, axillary, groin, throat and wound swabs in patients at risk for MRSA/SA colonization. The test is validated for use with the Sentosa® SX Lysis Beads (with nasal swabs) or Sentosa® SX Lysis Plate (96) (10x96) (with nasal, axillary, groin, throat and wound swabs), followed by automated PCR set-up on Sentosa® SX101 instrument or manual PCR set-up, in conjunction with PCR on the Rotor-Gene Q MDx 5plex HRM instrument and automated result calling and report generation with Sentosa® SA Reporter. The Sentosa® SA Direct MRSA/SA PCR Test (4x24) is intended to aid in the prevention and control of MRSA/SA infections in healthcare settings. It is not intended to diagnose, guide or monitor treatment for MRSA/SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

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