Bio·Firm

Primary DI

D-WI-MICR-C83A-25BP

Basic UDI-DI Code

B-WI-MICR-C83A-25BP

Reference

WI-MICR-C83A-25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Wantaifu Biotechnology Co., Ltd

SARS-CoV-2&Influenza AB Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test.It is designed for the rapid qualitative determination of SARS-CoV-2, Influenza A and Influenza B virus antigen in anterior Nasopharyngeal swab and nasal swabs from individuals suspected of SARS-CoV-2, Influenza A and Influenza B within the first 7 days of symptom onset. This test kit is intended use for individuals by clinical symptoms of SARS-CoV-2 、 Influenza A and Influenza B infection or who are suspected of SARS-CoV-2 、 Influenza A and Influenza B.Negative results shall not be used as sole basis to diagnose or exclude SARS-CoV-2, Influenza A and Influenza B infection. The SARSCoV-2&Influenza AB Antigen Combo Rapid Test Kit (LFIA) is intended for use by trained medical professionals.

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