COVID-19 SARS-CoV-2 Antigen Assay Kit (Colloidal Gold)

Primary DI

06970877681029

Basic UDI-DI Code

B-06970877681029

Reference

0103

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

COVID-19 Antigen Assay Kit (Colloidal Gold Method) is a lateral flow immunoassay for the qualitative detection of nucleaocapsid protein from SARS-CoV-2 in nasopharyngeal swab. It is intended to be used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test.

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