BNIBT

Primary DI

06975456580243

Basic UDI-DI Code

B-06975456580243

Reference

RICOV7

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 double antibody sandwich combines with colloidal gold immunochromatography. When an appropriate amount of the test sample is added into the sample hole of the test card, the sample will be move forward along the test card 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. The test card also contains a quality control line C, which should appear regardless of whether there is a test line. The quality control line C is the color belt of the quality control antibody immune complex. If quality control line C does not appear, it indicates that the test result is invalid, and the sample shall be retested with another test.

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