CoviDetect

Primary DI

D-5713915CD001LA98

Basic UDI-DI Code

B-5713915CD001LA98

Reference

8015, 8010, 8079

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PentaBase A/S

CoviDetect™ COVID-19 Multiplex RT-qPCR Assay is a semi-quantitative RT (Reverse Transcriptase) real-time Polymerase Chain Reaction (PCR) assay intended for the detection of nucleic acids from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. The assay is used with real-time PCR systems. SARS-CoV-2 RNA can be found in the upper or lower respiratory tracts of infected individuals. Samples can be obtained either by nasopharyngeal swabs, oropharyngeal swabs, and/or saliva. Samples can be purified on automated platforms or in manual workflows. The results of the CoviDetect™ COVID-19 Multiplex RT-qPCR Assay may aid in the diagnosis of coronavirus disease 2019 (COVID-19). The assay is provided in a multiplex format analysing two SARS-CoV-2 viral targets and one human target sampling control in the same PCR reaction tube. CoviDetect™ COVID-19 Multiplex RT-qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel 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).