Rapid SARS-CoV-2 Antigen Test Card

Primary DI

06921963711984

Basic UDI-DI Code

B-06921963711984

Reference

1N40C5

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Xiamen Boson Biotech Co., Ltd.

Rapid SARS-CoV-2 Antigen Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of SARS-CoV-2 virus antigen in nasal swabs, nasopharyngeal swabs or oropharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Rapid SARS-CoV-2 Antigen Test Card can not be used as the basis to diagnose or exclude SARS-CoV-2 infection. Rapid SARS-CoV-2 Antigen Test Card detects the SARS-CoV-2 nucleocapsid protein (N protein). Theoretically, genetic SARS-CoV-2 variants with non-nucleocapsid protein mutations do not affect the product performance.

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