Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
GENEDIAN
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-RA009UT
- Basic UDI-DI Code
- B-RA009UT
- Reference
- I121-01096; I121-01480
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou DIAN Biotechnology Co., Ltd.
Additional Description
SARS-CoV-2 Neutralizing Antibody Detection Kit (ELISA) is a Competitive Enzyme-Linked Immunosorbent Assay intended for qualitative and semi-quantitative detection of total neutralizing antibodies to SARS-CoV-2 in human serum and plasma.The SARS-CoV-2 Neutralizing Antibody Detection Kit(ELISA) can be used as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,indicating recent or prior infection. The SARS-CoV-2 Neutralizing Antibody Detection Kit should not be used to diagnose acute SARS-CoV-2 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
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