Fosun 2019-nCoV qPCR

Primary DI

06931654310075

Basic UDI-DI Code

B-06931654310075

Reference

PCSYHF02-e （48 tests/kit）

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Fosun Diagnostics (Shanghai) Co., Ltd.

The Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit is intended for the rapid detection of 2019-nCoV in human throat swab or sputum samples. Coronavirus is a + ssRNA virus with envelope. Its diameter is about 80-120 nm. Its genetic material is the largest of all RNA viruses. It is an important pathogen of many livestock, pets, including human diseases, and can cause many kinds of acute and chronic diseases. According to Virus Taxonomy-- Ninth Report of the International Committee on Taxonomy of Viruses, the Coronaviridae is divided into three genera: α, β and γ. Among them, α Coronavirus (such as human Coronavirus 229E, human Coronavirus NL63), β Coronavirus (such as human Coronavirus HKU1, human Coronavirus OC43 and SARS) can cause disease of varying degree to human. The common signs of people infected with coronavirus are respiratory symptoms, fever, cough, shortness of breath and dyspnea. In more serious cases, infection can lead to pneumonia, severe acute respiratory syndrome, renal failure, and even death. The "2019-nCoV" was named by WHO in January 12, 2020. According to the confirmed case request in New Coronavirus Pneumonia Prevention and Control Program (6th ed), clinical diagnosis case or suspected case has the following pathogenic evidences: RT-PCR detection result of 2019-nCoV in respiratory tract or blood sample is positive. This kit is intended for the detection of 2019-nCoV and is helpful for clinical diagnosis of 2019-nCoV infection.

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