SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

Primary DI

06971348761325

Basic UDI-DI Code

B-06971348761325

Reference

MF-71-5

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd Self Testing

Status

On The Market

Manufacturer

Shenzhen Microprofit Biotech Co., Ltd.

The fluorecare® SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit is applicable to the simultaneous qualitative detection and differentiation in vitro of novel Coronavirus (SARS-CoV-2) antigen, Influenza A virus antigen, Influenza B virus Antigen, and/or RSV antigen in nasal swab samples. It can be used as an aid in the diagnosis of coronavirus infectious disease (COVID-19) caused by SARS-CoV-2 in symptomatic patients within 7 days of onset and in the diagnosis of diseases caused by Influenza A/B or RSV. For in vitro diagnostic use only. For self-testing use.

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