RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS

Primary DI

06973492240206

Basic UDI-DI Code

B-06973492240206

Reference

U20208

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Ustar Biotechnologies (Hangzhou) Ltd.

This assay is an automated, in vitro nucleic acid amplification test used for qualitative diagnosis of Respiratory Syncytial Virus nucleic acid in human throat swabs collected from individuals with signs and/or symptoms of respiratory viral infection. It is used in the auxiliary diagnosis of respiratory infection. The agent detected may not be the definite cause of disease and the Clinical diagnostic information is necessary to determine infection status. This assay is not for near patient and self-testing.

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