RealAccurate® Quadruplex SARS-CoV-2 PCR Kit

Primary DI

08719327497906

Basic UDI-DI Code

B-08719327497906

Reference

PF0971C-R

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PathoFinder B.V.

RealAccurate® Quadruplex SARS-CoV-2 PCR Kit is a non-automated qualitative multiplex real-time PCR-based test to aid the diagnosis of respiratory infections in humans, by detecting within 2 hours Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19)), using 2 different genes: Nucleocapsid protein (N) gene and RNA-dependent RNA polymerase (RdRp). This test is intended for use on nucleic acids extracted from nasopharyngeal swab samples.

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