Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
FREND™ COVID-19 Ag+FLU A&B
Devices (same UDI-DI)
1
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 08809317541013
- Basic UDI-DI Code
- B-08809317541013
- Reference
- FRCGFL 020
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- NanoEntek, Inc.
Additional Description
The FREND™ COVID-19 Ag+FLU A&B is an in vitro diagnostic medical device based on fluorescence immunoassay (FIA) for use with the FREND™ System. It is designed for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 and nucleoprotein of Influenza A and B strains directly from nasopharyngeal swab specimens from individuals suspected with novel coronavirus disease 2019 (COVID-19) or/and flu by their healthcare provider.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040504 | INFLUENZA & PARA INFLUENZA - NA REAGENTS |
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
Available In Countries
🇩🇪 Germany
🇮🇹 Italy
🇷🇴 Romania
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