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

Primary DI

06974593880162

Basic UDI-DI Code

B-06974593880162

Reference

GZ-CG01

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 2019 novel coronavirus (SARS-CoV-2) antigen in saliva swabs, oropharyngeal swabs, nasal swabs in vitro, and to assist in the diagnosis of SARS-CoV-2 viral infection. 2019 Novel Coronavirus (SARS-CoV-2) belongs to the beta genus Coronavirus and was named by the World Health Organization on January 12, 2020. The main clinical manifestations of infected persons are fever, fatigue, and dry cough. A small number of patients have symptoms such as nasal congestion, runny nose, sore throat and diarrhea. Severe patients often develop dyspnea and/or hypoxemia one week after the onset. In severe cases, they rapidly progress to acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulopathy difficult to correct, etc. It is worth noting that severe and critically ill patients may have moderate to low fever during the course of their illness, or even no obvious fever. Mild patients only manifested as low-grade fever, mild fatigue, etc., without pneumonia. The patient showed multiple small patchy shadows and interstitial changes in the early stage, which were obvious outside the lungs. It then develops into multiple ground-glass shadows and infiltration shadows in both lungs. In severe cases, lung consolidation may occur, and pleural effusion is rare. SARS-CoV-2 Antigen Test Kit (Colloidal Gold) (hereinafter referred to as the kit) uses the colloidal gold method of immunochromatography, and the antibodies used are specific for novel coronavirus (SARS-CoV-2) ) N protein antigen. This product uses highly specific virus antibodies to detect relevant specific virus antigens.

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