COVID-19 Real Time Multiplex RT-PCR Kit

Primary DI

06438172312029

Basic UDI-DI Code

B-06438172312029

Reference

8100513

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Labsystems Diagnostics Oy

Labsystems Diagnostics’ Covid-19 Real Time Multiplex RT-PCR kit is developed for the rapid detection of COVID-19 viral infection by simultaneous targeting of three major genes ORF1ab, envelope (E), and nucleocapsid (N). The kit also includes an internal control to ensure successful extraction and amplification of viral RNA. The kit is for professional use only.

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