Liferiver Influenza and COVID-19 Real Time Multiplex RT-PCR Kit

Primary DI

06971042228476

Basic UDI-DI Code

B-06971042228476

Reference

RR-0491-02-200

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

SHANGHAI ZJ BIO-TECH CO., LTD

The Influenza and COVID-19 Real Time Multiplex RT-PCR Kit is an in vitro diagnostic test for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus RNA in upper respiratory tract specimens (such as nasopharyngeal, oropharyngeal and nasal swabs) collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider.1 Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing with the Influenza and COVID-19 Real Time Multiplex RT-PCR Kit is intended for use by trained laboratory personnel who are proficient in performing real-time RT-PCR assays. 1A healthcare provider includes, but is not limited to, physicians, nurses, pharmacists, technologists, laboratory directors, epidemiologists, or any other practitioners or allied health professionals.

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