BNIBT

Primary DI

06975456580229

Basic UDI-DI Code

B-06975456580229

Reference

RICOV0

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 capture reaction and combines with colloidal gold immunochromatography. The test card contains: 1) colloidal gold-labeled recombinant COVID-19 antigen and gold markers for quality control antibodies; 2) nitrocellulose membrane with two test lines (G and M lines) and one quality control line (C line). The M line is fixed with a monoclonal anti-human IgM antibody for detecting the COVID-19 IgM antibody; the G line is fixed with a reagent for detecting the COVID-19 IgG antibody; the C line is fixed with a quality control antibody.

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