Amplidiag COVID-19 Kit

Primary DI

06430041761365

Basic UDI-DI Code

B-06430041761365

Reference

AD-CV-864

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

Mobidiag Ltd.

Amplidiag COVID-19 test allows the rapid detection of novel coronavirus for large volumes (by batch). By allowing rapid and reliable detection of this novel coronavirus, this qualitative real-time RT-PCR test supports decisions to manage efficiently epidemiological and infection control measures, isolate patients in a timely manner and improve patient care globally. Amplidiag® COVID-19 detects 2 molecular targets including at least one conserved region and one specific region to mitigate against the effects of genetic drift and avoid cross-reaction with other endemic coronaviruses. The sample material is RNA extracted from a nasopharyngeal swab sample. 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).