Rapid COVID-19 + Influenza Antigen Test

Primary DI

06950996063111

Basic UDI-DI Code

B-06950996063111

Reference

GCFC-525a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Influenza is an acute and highly contagious viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA virus known as influenza viruses. There are three types of influenza viruses: A, B and C. Type A viruses are the most prevalent and are associated with most serious epidemics, while Type B infection is generally milder. Type C virus have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season and particular epidemic area. The disease is easily transmitted through coughing and sneezing of aerosolized droplets containing live virus. Influenza outbreaks normally occur each year during fall and winter seasons. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Entire human population is susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, dry cough, and loss of taste and smell. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

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