RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

Primary DI

06974858560822

Basic UDI-DI Code

B-06974858560822

Reference

P770H

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Suzhou TianLong Biotechnology Co., Ltd.

The test is designed to detect RNA from Influenza A/ Influenza B/ Respiratory Syncytial Virus (RSV)/SARS-CoV-2 in specimens such as nasopharyngeal or oropharyngeal swabs collected from individual personnel based on clinical and/or epidemiological criteria. Other sample types from the upper and lower respiratory tract (such as sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate), as well as samples collected from the environment, may serve the purpose for virus detection as well if adequate Influenza A/ Influenza B / Respiratory Syncytial Virus (RSV)/SARS-CoV-2 RNA could be extracted from the samples.

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