BOIRON

Primary DI

06973861680299

Basic UDI-DI Code

B-06973861680299

Reference

A6061253

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Anbio (Xiamen) Biotechnology Co.,Ltd.

The Rapid COVID-19 Antigen Test is a colloidal gold immunochromatography intended for the qualitative detection of nucleocapsid antigens from SARS-Cov-2 in human Nasopharyngeal swabs, Nasal swabs, Throat swabs and Saliva from individuals who are suspected of COViD-19 by their healthcare provider. The novel coronaviruses belong to the β genus of Coronaviruses. COvID-19 is an acute respiratory infectious disease.People are generaly 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. Test results are for the identification of SARS-CoV-2 nucleocapsid antigen. The antigen is generally detectable in upper respiratory samples or lower respiratory samples during the acute phase of infection.The positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. The positive results do not rule out bacterial infection or co-infection with other viruses. The antigen detected may not be the definite cause of disease. The negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.The negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with SARS-Cov-2 and confirmed with a molecular assay, if necessary, for patient management.

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