Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06975379900005
- Basic UDI-DI Code
- B-06975379900005
- Reference
- DXK007-1
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Nanjing Genscript Diagnostics Technology Co., Ltd.
Additional Description
The SARS-CoV-2 Neutralizing Antibody Test Kit can be used for in-vitro qualitative detection of SARS-CoV-2 neutralizing antibody in human fingertip blood samples, which can be used to assess the levels of neutralizing antibodies produced in the body after vaccination infection with novel coronaviruses (COVID-19).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-110/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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