Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
FREND COVID-19 Ag
Devices (same UDI-DI)
1
Certificates
0
Countries
6
Notified Bodies
0
Basic Information
- Primary DI
- 08809317541136
- Basic UDI-DI Code
- B-08809317541136
- Reference
- FRCOG-J 020P
- 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 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 directly from nasopharyngeal swab from individuals suspected with novel coronavirus disease 2019 (COVID-19) by their healthcare provider.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Available In Countries
🇧🇪 Belgium
🇪🇸 Spain
🇭🇺 Hungary
🇮🇹 Italy
🇷🇴 Romania
🇸🇮 Slovenia
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