Sentosa SA C. diff PCR Test v2.0 (4x24)

Primary DI

08885013953046

Basic UDI-DI Code

B-08885013953046

Reference

3000249

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The Sentosa® SA C. diff PCR Test v2.0 is a real-time polymerase chain reaction (PCR) based in vitro diagnostic test, targeting toxin B gene (tcdB) in the toxigenic Clostridium difficile strains, for the qualitative detection of C. difficile nucleic acids isolated and purified from liquid or soft stool obtained from symptomatic patients. This in vitro diagnostic test is configured for use on the Sentosa® SX101 instrument, with the Sentosa® SX Virus Total Nucleic Acid 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. Negative results do not preclude C. difficile 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).