BOIRON

Primary DI

06973861680480

Basic UDI-DI Code

B-06973861680480

Reference

B6061403

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Suny (Xiamen) Biotechnology Co., Ltd.

This kit is a colloidal gold immunochromatography intended for the simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, In􀏐luenza A and In􀏐luenza B vira in human direct Nasal Swab specimens. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and in􀏐luenza can be similar. This kit is suitable for detection symptomatic or asymptomatic SARS-CoV-2, In􀏐luenza A and In􀏐luenza B suspected cases, patients with suspected clusters or other individuals who need to be diagnostic with SARS-CoV-2, in􀏐luenza A and in􀏐luenza B infection.

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