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

Primary DI

06973492240299

Basic UDI-DI Code

B-06973492240299

Reference

U20223

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ustar Biotechnologies (Hangzhou) Ltd.

This kit is used for the in vitro qualitative detection of the novel coronavirus (2019-nCoV) ORF1ab gene, N gene in nasopharyngeal and oropharyngeal swabs, sputum, saliva samples from patients with suspected cases of pneumonia with novel coronavirus infection, patients with suspected clustered cases, and others who require a novel coronavirus infection diagnosis or differential diagnosis. The defnitions of "suspected cases" and "suspected clustered cases" and other groups are implemented with reference to documents such as the "Pneumonitis Diagnosis and Treatment Program for Novel Coronavirus Infection" and "Monitoring Scheme for Pneumonia Cases with Novel Coronavirus Infection." Carrying out the detection of novel coronavirus (2019-nCoV) RNA should meet the requirements of "Technical Guide for Laboratory Testing of Pneumonia of Novel Coronavirus Infection" and take good biological protection measures. The results of the kit are for clinical reference only and should not be used as the sole standard for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition in combination with the clinical manifestations of the patient and other laboratory tests.

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