2019-Novel Coronavirus(2019-nCoV) IgG/IgM GICA Rapid Test

Primary DI

06974521004585

Basic UDI-DI Code

B-06974521004585

Reference

SUPG223025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro qualitative detection of 2019-nCoV antibodies in human serum, plasma, and whole blood samples. It is only used as a supplementary test for suspected cases with negative nucleic acid test or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. It cannot be used as the basis for the diagnosis and exclusion of pneumonia caused by 2019-nCoV, and it is not suitable for general population screening. This kit is for medical institutions use only.

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