VIROLOGY - RT & POC - OTHER

Primary DI

06934822526018

Basic UDI-DI Code

B-06934822526018

Reference

1 Test/Box

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.

COVID-19 Antigen Rapid Test Kit (Colloidal Gold)- for self-testing is an immunochromatography assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus (SARS-CoV-2) antigen from the nasal swab specimen of the symptomatic individual in the first 7 days from the onset of symptoms. This test is for self-test in non-healthcare settings (such as person’s home or certain non-traditional sites such as offices, airports, schools etc.) by individuals and results are for the detection of SARS-CoV-2 antigen. The test provides preliminary test results. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. A positive test result indicates SARS-CoV-2 infection, but further medical tests are needed to confirm infection. Negative results, on the other hand, do not completely rule out a SARS-CoV-2 infection. Negative results must be confirmed by a doctor, especially if symptoms of COVID-19 are present.

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