BGI

Primary DI

05745000468140

Basic UDI-DI Code

B-05745000468140

Reference

MFG030029

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

BGI EUROPE A/S

Intended Use: This kit is an immunoassay used for in vitro qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swabs specimens from symptomatic suspects of COVID-19 within the 7 days post symptom onset. This kit is for personal use by untrained layman as a rapid test method for SARS-CoV-2 antigen detection. It is suitable for users over 15 years old. Users under 15 years of age should be tested with assistance of adult.COVID-19 is an acute infectious disease of the respiratory system caused by the infection of the SARS-CoV-2 virus.. Symptoms may appear 2-14 days after exposure to the virus. Anyone can have mild to severe symptoms. Some people even suffer critical symptoms (respiratory failure, shock, or multiorgan dysfunction, etc.). Older people are at a higher risk of developing severe symptoms. SARS-CoV-2 is a novel coronavirus in β genus, enveloped particles in round or oval, with a diameter from 60 nm to 140 nm. Human is generally susceptible to SARS-CoV-2. The main sources of infection are the confirmed COVID-19 patients and asymptomatic carriers of SARS-CoV-2. SARS-CoV-2 is detectable in specimen of oropharyngeal swab, nasopharyngeal swab, anterior nasal swab and saliva. Detection of SARS-CoV-2 antigen can provide evidence for assessing the infection situation and aiding clinical diagnosis of COVID-19.

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