Amplidiag C. difficile+027 Kit

Primary DI

06430041761532

Basic UDI-DI Code

B-06430041761532

Reference

AD-CD-300

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

Mobidiag Ltd.

"Amplidiag C.difficile+027 Kit is a qualitative multiplex nucleic acid-based in vitro diagnostic test intended for detecting the presence of nucleic acid markers corresponding to the detection and identification of toxin B producing Clostridium difficile strains and discrimination of its hypervirulent 027 ribotype in stool specimens from patients with symptoms of C. difficile associated disease. The assay is based on multiplexed real-time PCR amplification in conjunction with fluorophore-labelled probes. The product consists of test reagent set and software kit configuration containing the analysis parameters."

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