Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
FREND™ COVID-19 Neutralization Ab
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 08809317541075
- Basic UDI-DI Code
- B-08809317541075
- Reference
- FRCON 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 Neutralization Ab is a point-of-care testing (POCT) which can be used to check whether a patient has developed the immune response to SARS-CoV-2 using human serum and plasma (EDTA). The FREND™ COVID-19 Neutralization Ab is a fluorescence immunoassay (FIA) using the FREND™ System intended for the qualitative detection of neutralization antibodies to SARS-CoV-2. The FREND™ COVID-19 Neutralization Ab is an in vitro diagnostic medical device which is intended for use as an aid in identifying individuals with neutralizing antibodies to SARS-CoV-2 after vaccination or prior infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
Available In Countries
🇩🇪 Germany
🇷🇴 Romania
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries