INFLUENZA A AND /OR B - RT & POC

Primary DI

06975977071602

Basic UDI-DI Code

B-06975977071602

Reference

600160

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Gold Probe Diagnostic Biotechnology Inc. MF

The kit is used for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA in Oropharyngeal swab, nasal swab and Saliva sample from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Rapid and accurate diagnosis and differentiation of SARS-CoV-2 and influenza infections is important in individuals suspected of a respiratory infection. This product can be operated in a non-laboratory protective environment and can realize POCT rapid detection.

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