Flu AB + COVID-19 Antigen Combo Test Cassette Kit

Primary DI

06970895474115

Basic UDI-DI Code

B-06970895474115

Reference

R218T020B1C0

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Mole Bioscience Co., LTD.

The test is intended for use in the rapid detection and differentiation of influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen, but does not differentiate, between SARS-CoV and COVID-19 viruses and is not intended to detect influenza C antigens. Performance characteristics may vary against other emerging influenza viruse. Influenza A, influenza B and COVID-19 virus 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 statu. The In fluenza A , Influenza B and COVID-19 Antigen Combo Test Kit is intended for the influenza A,influenza B and COVID-19 antigens in the nasal swab, Nasopharyngeal swab samples. The test provides preliminary test results. Negative results cannot exclude COVID-19 ,influenza A or influenza B virus infection and they cannot be used as the sole basis for treatment or other management deci.

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