REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS

Primary DI

06973492240343

Basic UDI-DI Code

B-06973492240343

Reference

U20227

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ustar Biotechnologies (Hangzhou) Ltd.

This product is suitable for in vitro qualitative detection of the novel coronavirus (2019-nCoV) ribonucleic acid (RNA) in human oropharyngeal swab, nasopharyngeal swab and sputum. 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 epidemio-logical 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).