COVID-19 In Vitro Diagnostic Medical Device - detail

Device identification number

2967

CE Marking

✓Yes

HSC common list (RAT)

×No

Commercial Status

Commercialised

Last Update

2022-12-02 09:22:17 CET

Comments

COVID-19 Ag Test is the chromatographic assay test used for qualitative detection of the COVID-19 nucleoprotein antigen in nasal swab specimen from suspected patients may infected COVID-19. It is intended to be used in self-testing. COVID-19 Ag Test provides preliminary test results. And negative results don’ t preclude COVID-19 Ag infection. The test kit cannot be used as the sole basis for treatment or other management decision. For in vitro diagnostic use only. People under the age of 15 should be tested by a guardian, and people over 70 years old should seek help from others for swab specimen collection. If the test result is negative but still with the present symptoms, it is recommended to consult a doctor for confirmation in time.A nasal swab sample can be self-collected by an individual aged 15-70 years. People are unable to collect samples by themselves may be assisted by other adults. Infants or small children should be tested by medical staff. The test is suitable for symptomatic and asymptomatic patients. It is recommended for symptomatic patients.