SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test

Primary DI

16972698604284

Basic UDI-DI Code

B-16972698604284

Reference

P211147

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.

SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test is intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus in direct nasal or nasopharyngeal specimens. It’s an in vitro diagnostic test for professional use only. 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, Influenza and RSV can be similar. SARS-CoV-2, Influenza A, Influenza B and RSV 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).