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

Primary DI

06937044500378

Basic UDI-DI Code

B-06937044500378

Reference

XC111

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 rapid qualitative self-detection of SARS-CoV-2 ORF1ab and N genes in throat swab samples of suspected cases of novel coronavirus pneumonia, suspected cluster cases, and others who need to be diagnosed or differentially diagnosed with novel coronavirus infection gene and ORF1ab/N gene. The kit is composed of four components: Sampling swabs, sample processing tubes, reaction tubes, and colloidal gold strips. Simple operation, from sampling to results can be completed in 30 minutes. The product is for professional use only. Not for self-testing.

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