RSV Rapid Test Device (Swab)

Primary DI

06976753475690

Basic UDI-DI Code

B-06976753475690

Reference

A431301D

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Cybereagen Biotech Co., Ltd.

Respiratory Syncytial Viral Rapid Test Device (Swab) is an in vitro diagnostic test for the qualitative detection of Respiratory Syncytial Virus antigens in Nasal Swab and nasal aspirate samples, using the rapid immunochromatographic method. The identification is based on the monoclonal antibodies specific for the F protein of the Respiratory Syncytial Virus. It will provide information for clinical doctors to prescribe correct medications. Negative results should be confirmed by other methods, such as cell culture.

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