COVID-19 SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold)

Primary DI

06970877683009

Basic UDI-DI Code

B-06970877683009

Reference

0301

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

For vitro qualitative detection of Anti-SARS-CoV-2 antibody from serum、plasma and whole blood samples. It is only intended for the supplementary indicator for suspected cases of negative SARS-CoV-2 nucleic acid detection, or combination with nucleic acid detection in the diagnosis of suspected cases. Results from antibody testing should not be used as the sole basis to diagnose or exclude COVID-19. It is not intended for screening in general population. Positive test results need further confirmation. Negative results do not exclude SARS-CoV-2 infection. These kits are for medical use only.

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