Amplidiag CarbaR+ VRE Kit

Primary DI

06430041761471

Basic UDI-DI Code

B-06430041761471

Reference

AD-CP-100

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

Mobidiag Ltd.

"Amplidiag CarbaR+VRE Kit identifies clinically most relevant carbapenemase groups as well as vancomycin resistance markers in one single test. This molecular diagnostic test has been designed to be a cost-effective solution for high-volume screening from stool samples, rectal swabs or pure culture samples for the diagnosis of carbapenemase-producing organisms (CPO) and vancomycin-resistant Enterococci (VRE). This qualitative multiplex real-time PCR test gives results within a few hours. 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).