CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

Primary DI

06972412611874

Basic UDI-DI Code

B-06972412611874

Reference

303036-05

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Hangzhou Laihe Biotech Co., Ltd.

The OWNTM antigen test kit for the novel coronavirus (SARS-CoV-2, which causes COVID-19) is adiagnostic test. The test is to be used as an aid in the rapid diagnosis of infection with SARS-CoV-2The test is used for the direct and qualitative detection of viral protein (the antigen: N protein) ofSARS-CoV-2 in nasal mucus. The rapid test uses highly sensitive antibodies to measure the Nprotein. With this self-testing test, you can find out if you are infected with the virus causedCOVID-19. To be used as a self-test from the age of 16. For children under the age of 16, a legalguardian will perform the test or the test will be done under their supervision.A negative result of the OWNTM Novel Coronavirus (COVID-19) Antigen Test Kit does not excludeinfection with COVID-19. lf symptoms are suggestive of COVID-19, a negative result should beverified by laboratory test.

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