INFLUENZA A AND /OR B - RT & POC

Primary DI

06975132462214

Basic UDI-DI Code

B-06975132462214

Reference

ICMCAB-502G-1

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Accuracy Biotechnology Co.,Ltd.

COVID-19/Influenza A&B Antigen Rapid Test Kit (Colloidal Gold) is an immunochromatographic assay for rapid, it is designed for the rapid qualitative detection of severe acute respiratory syndrome coronavirus (SARS-CoV-2) Antigen and Influenza A&B virus nucleoprotein antigen from the nasopharyngeal swab specimen or oropharyngeal swab specimen. The test provides preliminary test results. The test is to be used as an aid in the diagnosis of SARS-CoV-2 and Influenza A&B virus infection. This test card cannot be used as the basis to diagnose or exclude SARS-CoV-2 and Influenza A&B virus infection.

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