Rotavirus Rapid Test Cassette (Feces)

Primary DI

06950996002462

Basic UDI-DI Code

B-06950996002462

Reference

GCROA-602a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young children. Its discovery in 1973 and its association with infantile gastro-enteritis represented a very important advancement in the study of gastro-enteritis not caused by acute bacterial infection. The rotavirus may still be found while diarrhoea continues. Rotaviral gastroenteritis may result in mortality for populations at risk such as infants, the elderly, and immunocompromised patients. In temperate climates, rotavirus infections occur mainly in the winter months. Endemics as well as epidemics affecting some thousand people have been reported. With hospitalised children suffering from acute entric disease up to 50% of the analysed specimen were positive for rotavirus. The viruses replicate in the cell nucleus and tend to be host species specific producing a characteristic cytopathic effect (CPE). Because rotavirus is extremely difficult to culture, it is unusual to use isolation of the virus in diagnosing an infection. Instead, a variety of techniques have been developed to detect rotavirus in feces.

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