CoviFLU

Primary DI

D-5713915CD005LJAE

Basic UDI-DI Code

B-5713915CD005LJAE

Reference

8177, 8180

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

CoviFlu™ COVID-19 & Influenza RT-qPCR Assay is a semi-quantitative real-time RT (Reverse Transcriptase) Polymerase Chain Reaction (PCR) with end-point melt-analysis intended for the quantitative detection and identification of RNA from SARS-CoV-2 and four common strains of influenza (B Yamagata, B Victoria, A H1N1, and A H3N2) viruses. The assay is used with real-time PCR systems. Viral RNA can be found in the upper or lower respiratory tracts of infected individuals. Samples can be obtained by nasopharyngeal swabs, oropharyngeal swabs, and/or saliva. Samples can be purified on automated platforms or in manual workflows. CoviFlu™ COVID-19 & Influenza RT-qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel specifically instructed and trained in the techniques of Real-Time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.

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