Respiratory Multiplex RT-PCR Kit

Primary DI

06438172315013

Basic UDI-DI Code

B-06438172315013

Reference

8100532

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Labsystems Diagnostics Oy

Labsystems Diagnostics’ Respiratory Multiplex RT-PCR Kit is developed for the rapid real-time detection of SARS-CoV-2, influenza A, influenza B and RSV A/B viral infections by simultaneous targeting of a gene from each target. These genes are the open reading frame 1ab (ORF1ab) for SARS-CoV-2, matrix (M) for influenza A, hemagglutinin (HA) for influenza B and matrix (M) and RNA polymerase L (L) for RSV A/B. The kit also targets an internal control gene, human ß-globin, to ensure successful extraction and amplification of viral RNA.

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