Novodiag Bacterial GE+

Primary DI

06430041761761

Basic UDI-DI Code

B-06430041761761

Reference

NVD-BGE-012

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

Mobidiag Ltd.

"Novodiag Bacterial GE+ assay is an integrated sample-to-answer cartridge product, composed of sample preparation, DNA amplification, microarray hybridization detection and automated qualitative result interpretation via an assay specific software plug-in. It is designed for diagnosis of community and hospital acquired bacterial infections from stool samples. The product consists of test cartridge and software assay plugin containing the run and analysis parameters."

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