BNIBT

Primary DI

06975456580267

Basic UDI-DI Code

B-06975456580267

Reference

RICOV6

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 antigen sandwich method and combines with colloidal gold immunochromatography. The test card contains: 1) colloidal gold labeled recombinant sRBD1 antigen; 2) nitrocellulose membrane with test lines (T line) and one quality control line (C line). The T line is fixed with sRBD2 Antigen. 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 neutralizing antibody, the antibody will bind to the colloidal gold-labeled sRBD1 antigen. The immune complex will be captured by sRBD2 antigen immobilized on the membrane to form a sRBD1-Antibody- sRBD2 complex, showing a purple-red T line. 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).