COVID-19 (SARS-CoV-2) Antigen Test Kit

Primary DI

06973720138404

Basic UDI-DI Code

B-06973720138404

Reference

W-AgH-20S

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

Brand name: Selfdiagnostics Type: B This kit is intended for in vitro qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19. The kit is suitable for layperson use, children under age of 14 should be assisted by an adult. Please always seek for assistance and supervision with the test when needed and follow your local guidelines for specimen collection by children. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. 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.

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