Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
CORONAVIRUS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06970277517539
- Basic UDI-DI Code
- B-06970277517539
- Reference
- INCP-502H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
A rapid test for the qualitative detection of SARS-CoV-2 Nucleocapsid Protein antigens present in nasal swab specimen.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-035/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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