Diagnostic Kit for Group A Rotavirus (Colloidal Gold)

Primary DI

06970877681210

Basic UDI-DI Code

B-06970877681210

Reference

1101

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Kangmei Tianhong Biotech (Beijing) Co., Ltd.

This kit is used for in vitro qualitative detection of Group A rotavirus antigen in infant stool samples. Rotavirus is a double stranded RNA virus, which mainly infects intestinal epithelial cells, causing cell damage and diarrhea. Group A rotavirus is one of the main pathogens causing diarrhea in infants and young children. It is prevalent in autumn and winter every year. The route of infection is fecal oral. Its clinical manifestations are acute gastroenteritis, which is a osmotic diarrhea disease. The course of disease is generally 7 days, with fever, vomiting, diarrhea and other symptoms, and dehydration in severe cases. Common detection methods include electron microscopy, polymerase chain reaction for detection of viral nucleic acid, enzyme-linked immunosorbent assay for detection of viral antigen, etc. This kit is used to assist in the diagnosis of group A rotavirus infection in clinical infants.

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