Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
SARS-CoV-2 Neutralization Antibody Detection Kit (Colloidal Gold),
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06971042229633
- Basic UDI-DI Code
- B-06971042229633
- Reference
- CG-0004-20
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SHANGHAI ZJ BIO-TECH CO., LTD
Additional Description
The SARS-CoV-2 Neutralization Antibody Detection Kit (Colloidal Gold) is an in vitro diagnostic test used for the qualitative detection of Novel coronavirus (SARS-CoV-2) neutralizing antibody in human fingerstick whole blood. It is only used to evaluate the humoral immune effect after complete vaccination of mRNA vaccine against COVID-19. It can not serve as basis for the diagnosis and exclusion of pneumonia caused by Novel coronavirus (SARS-CoV-2) infection, and cannot be used as an evaluation of vaccine immunity.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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