CORONAVIRUS [obsolete from 2025-01-01]
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Basic Information
- 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.
Additional Description
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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
| W0105099004 | INFLUENZA A AND /OR B - RT & POC |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).