BGI

Trade name

BGI

05745000468140

B-05745000468140

Reference / catalog number

MFG030029

GS1

IVDD — Self-testing

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105040519CORONAVIRUS - NA REAGENTSInactive

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• Caution

  This product is only used for in vitro diagnosis, and it is for presumptive screening only and the need to consult a medical practitioner for confirmatory testing of positive results by a laboratory test and for follow-up clinical care,. Please read the instructions carefully before testing.