SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

Primary DI

06974167891594

Basic UDI-DI Code

697416789100NQ

Reference

123143-02-102

Device Types

Single use New device Sterile

Regulation

Eu Ivdr

Classification

Eu Ivd Class D

Status

On The Market

Manufacturer

Jiangsu Medomics Medical Technology Co.,Ltd.

SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA) is an immunochromatography based one step in vitro test. It is designed for the qualitative detection of the SARS-CoV-2 virus, Influenza A virus, Influenza B virus, Adenovirus and Respiratory syncytial virus in human anterior nasal swab samples. The test results are used for the auxiliary diagnosis of respiratory pathogen infections, and are suitable for people with clinical symptoms such as fever, sore throat, cough, runny nose. The test kit is designed for use as self-testing. This test kit can be used independently by individuals who are 18 or older. For those under the age of 18, it should be operated or supervised by an adult. This test kit is not used in combination with other equipment and is not automated.

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class D) and regulation (EU IVDR).