Rapid Rota-Adenovirus Combo Test

Primary DI

06936155804573

Basic UDI-DI Code

B-06936155804573

Reference

ITP14003-TC20

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

InTec PRODUCTS, INC.

The Rapid Rota-Adenovirus Combo Test is a rapid immunochromatographic assay forthe qualitative detection of Rotavirus and Adenovirus antigen in human fecesspecimen. This test is a rapid test as an aid in the diagnosis of relative infection and tomonitor the effectiveness of therapeutic treatment; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed inconnection with other clinical information, e.g. clinical symptoms, and alternate test tomake final decision. This test is for in-vitro diagnostic use only.

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