VIROLOGY - RT & POC - OTHER

Primary DI

06936791030022

Basic UDI-DI Code

B-06936791030022

Reference

XG030312

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

The 2019-nCoV Antigen Test (Lateral Flow Method) is intended for the in vitro qualitative detection of the N-protein antigen from 2019-nCoV in oropharyngeal or nasopharyngeal swab specimens collected from individuals in suspected or cluster of COVID-19 cases, or other individuals who are in need of diagnosis or identification of 2019-nCoV infections. The 2019-nCoV Antigen Test should not be used solely for the diagnosis of 2019-nCoV infection, which should be done in combination with other diagnostic information from nucleic acid testing, imaging examination, etc. as well as medical history and contact history.

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