SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

Primary DI

06974593880155

Basic UDI-DI Code

B-06974593880155

Reference

GZ-CGS25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shanghai GeneoDx Biotech Co., Ltd.

This product is used to qualitatively detect the novel coronavirus (SARS-CoV-2) antigen in human saliva samples in vitro. It can be used for rapid investigation of suspected novel coronavirus cases, and can also be used as a reconfirmation method for nucleic acid detection in discharged cases. A positive test result requires further confirmation, and a negative test result cannot rule out the possibility of infection. This kit is for home use by laymen in a non-laboratory setting (such as person' s home or certain non-traditional sites such as offices, sporting events, airports, schools etc.). It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.

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