Hoyotek

Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) Self-testing

【Model】

HYT-G01-04 Nasal Swab  

【Intended use】

The Corona Virus (COVID-19) Antigen Rapid Test (Colloidal Gold) is a lateral flow immunoassay for qualitative detection of nucleocapsid protein of Severe Acute Respiratory Syndrome Corona virus 2 (SARS-CoV-2) in direct nasal swabs of individuals suspected of COVID-19 infection within the first 7 days of symptom onset and patients with asymptomatic infections. In individuals without COVID-19 symptoms and/or individuals who live in areas with low numbers of COVID-19 infections and without known exposure to COVID-19, more false positive results may occur. Testing of individuals without symptoms should be limited to contacts of confirmed or probable cases or to other epidemiological reasons to suspect a COVID-19 infection and should be followed by additional confirmatory testing with a molecular test.

【Certification】

ISO 13485 

Notified Body CE Certificate & Thailand FDA

EU ID: 3562 TFDA ID:T6400149