Flu & COVID-19 Antigen Duo Rapid Test

Primary DI

16972698604277

Basic UDI-DI Code

B-16972698604277

Reference

P211146

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

Flu & COVID-19 Antigen Duo Rapid Test is intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasal specimens. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of virus. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. SARS-CoV-2, influenza A and influenza B viral antigens are generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.(25 pcs/kit)

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