INFLUENZA A AND /OR B - RT & POC

Primary DI

06950917930300

Basic UDI-DI Code

B-06950917930300

Reference

C011928

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Triplex International Biosciences (China) Co., LTD.

This Flu A & B Rapid Test Kit is only used for rapid in vitro qualitative detection of influenza A and 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 influenza A and B viral infections. Negative test results do not preclude influenza infection 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).