ViroKey SARS-CoV-2 RT-PCR Test

Primary DI

08885013956634

Basic UDI-DI Code

B-08885013956634

Reference

300680

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

ViroKeyTM SARS-CoV-2 RT-PCR Test is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of nucleic acids from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection. Positive results are indicative of active infection. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

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