BNIBT

Primary DI

06975456580212

Basic UDI-DI Code

B-06975456580212

Reference

10005844

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing North Institute of Biotechnology Co.,Ltd.

The reagent utilizes the principle of colloidal gold immunochromatography. When an appropriate amount of the test sample is added into the sample hole of the test cassette, the sample will be move forward along the test cassette under the action of capillary. If the sample contains covid-19 antigen, the antigen will bind to the colloidal gold-labeled COVID-19 antibody. The immune complex forms a sandwich complex with another coated COVID-19 antibody at the detection line (T line), showing that the COVID-19 antigen is positive.

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