VIROLOGY - RT & POC - OTHER

Primary DI

06975132462122

Basic UDI-DI Code

B-06975132462122

Reference

ICOV-502G-3

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Jiangsu Accuracy Biotechnology Co.,Ltd.

COVID-19 Antigen Rapid Test Kit (Colloidal Gold) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus (SARS-CoV-2) antigen from the nasal swab specimen, oropharyngeal swab specimen or nasopharyngeal swab specimen. The test provides preliminary test results. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. This product cannot be used as the basis to diagnose or exclude SARS-CoV-2 infection.

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