Novodiag RESP-4

Primary DI

06430041761525

Basic UDI-DI Code

B-06430041761525

Reference

Novodiag RESP-4

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

Mobidiag Ltd.

The Novodiag® RESP-4 test is a molecular random-access test, easy to use that aids in the detection and differentiation of RNA from SARS-CoV-2, influenza A and B and RSV A/B viruses. The test includes two SARS-CoV-2 specific gene targets and reports them separately to eliminate false negative results due to potential target mutations. The test detects also clinically associated influenza A subtypes and clades of A(H1N1), A(H3N2), and A(H5N1), and their variants as well as two influenza B lineages: B/Yamagata and B/Victoria and RSVA and B.

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