VIROLOGY - RT & POC - OTHER

Primary DI

06950917930348

Basic UDI-DI Code

B-06950917930348

Reference

C011932

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Triplex International Biosciences (China) Co., LTD.

This SARS-CoV-2 & Flu A+B Antigen Combo Rapid Test Kit is only used for rapid in vitro qualitative detection of SARS-CoV-2, influenza A and influenza B nucleoprotein antigens in the nasopharyngeal swab, nasal swab, oropharyngeal swab or saliva specimens. It is intended to aid in the rapid differential diagnosis of SARS-CoV-2, influenza A and influenza B viral infections. Negative test results do not preclude SARS-CoV-2 or influenza infections and should not be used as the sole basis for treatment or other patient management decisions.

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