2019 Novel Coronavirus Antigen Rapid Test(Colloidal Gold)

Primary DI

06972665703012

Basic UDI-DI Code

B-06972665703012

Reference

Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]

Device Types

Single use Sterilization

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

XIAMEN SPACEGEN CO.,LTD.

This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human throat swabs or nasal swabs. The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

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