GENEDIAN

Primary DI

D-RA012UG

Basic UDI-DI Code

B-RA012UG

Reference

P122-06048

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou DIAN Biotechnology Co., Ltd.

This kit is used for the qualitative detection of Novel Coronavirus (SARS-CoV-2), influenza A and influenza B viruses in human throat swabs in vitro, as well as for Novel Coronavirus with symptoms of fever and other respiratory tract infections. The main suspects are suspected cases of Novel Coronavirus, influenza A virus, influenza B virus infection, suspected aggregation cases, and other patients who need to diagnose or differentiate fever and respiratory tract infection. The detection of influenza A and influenza B viruses by this kit is universal. The detectable subtypes include influenza A virus H1N1, influenza A virus H1N1 (2009), influenza A virus H3N2, influenza A virus H5N1, influenza A virus H7N9, influenza B virus Victoria, influenza B virus Yamagata . The detection result is for use as the clinical reference only and should not be used as the sole standard for the diagnosis of SARS-COV-2 and FluA/FluB, it is suggested to be used in combination with patient’s symptoms and other IVD results for accurate diagnosis and overall evaluation of disease progress.

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