ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)

Primary DI

08885013953824

Basic UDI-DI Code

B-08885013953824

Reference

301069

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Vela Operations Singapore Pte. Ltd.

The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is a real-time RT-PCR based in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and saliva 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 swabs, oropharyngeal swabs and saliva during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. 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).