CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

Primary DI

06937044500774

Basic UDI-DI Code

B-06937044500774

Reference

XC25103

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ningbo HEALTH Gene Technologies Co., LTD.

This product is used for in vitro qualitative detection of SARS-CoV-2 Virus antigens in human 6 / 15 nasalswabs and oropharnaealswabs. Auxiliary diaanosis for SARS-CoV-2 Virus infection. The novel coronaviruses belong to the qenus.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. fatiaue and dry cough Nasal congestion, runny nose, sore throat, myalqia and diarrhea are found in a few cases.

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