Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
FREND™ COVID-19 SP
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08809317541082
- Basic UDI-DI Code
- B-08809317541082
- Reference
- FRCOSW 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 SP is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System. FREND ™ COVID-19 SP is an in vitro diagnostic medical device that helps identify coronavirus disease 2019 (COVID-19) infections.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040699 | VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER |
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