CORONAVIRUS [obsolete from 2025-01-01]

Primary DI

D-WHATOCOVFLUF9

Basic UDI-DI Code

B-WHATOCOVFLUF9

Reference

WH-AT-OCOVFLU

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

W.H.P.M. Bioresearch & Technology Co., Ltd.

The COVID-19 / Flu A+B Antigen Combo Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from both COVID-19 and Influenza A and B in nasopharyngeal swab (NP), anterior nasal swab (NS) and oropharyngeal swab (OS) specimens, from individuals suspected of COVID-19or Influenza A or B by their healthcare provider within the first seven days of symptom onset. The COVID-19 portion of the COVID-19 / Flu A+B Antigen Combo Rapid Test does not differentiate between SARS-CoV and COVID-19 . The influenza portion, however, can differentiate between influenza A and B.

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