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

Primary DI

06937044500811

Basic UDI-DI Code

B-06937044500811

Reference

XC25073

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ningbo HEALTH Gene Technologies Co., LTD.

This kit is used for in vitro qualitative detection of novel SARS-CoV-2 ORF1ab in throat swab samples of suspected cases of novel coronavirus pneumonia, patients with suspected cluster cases, and other people who need to be diagnosed or differentially diagnosed with novel coronavirus infection gene and N gene.The definitions of "suspected cases" and "patients with suspected cluster cases" should refer to the "Diagnosis and Treatment Program for Novel Coronavirus Infected Pneumonia" and the "Monitoring Program for Novel Coronavirus Infected Pneumonia Cases" (current version). To carry out the nucleic acid test of the new coronavirus, it should meet the requirements of the "Technical Guidelines for Laboratory Testing of Novel Coronavirus Pneumonia" and other requirements, and do a good job in biosafety. 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).