VIROLOGY - RT & POC - OTHER

Primary DI

06975445472016

Basic UDI-DI Code

B-06975445472016

Reference

COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) Specimens: Nasopharyngeal swab/ Nasal swab

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

FARMASINO MEDICAL CO., LTD

The COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) is a lateralflow immunoassay using highly sensitive monoclonal antibodies that are specific for COVID-19 antigen The test is specific to COVID-19 antigens with no known cross-reactivity to normal flora or other known respiratory pathogens. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally 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 and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

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