Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
BNIBT
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06975456580205
- Basic UDI-DI Code
- B-06975456580205
- Reference
- 10005844
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Beijing North Institute of Biotechnology Co.,Ltd.
Additional Description
An immunochromatographic assay for the rapid qualitative detection of COVID-19 antigen in human nasopharyngeal swabs as an assistant for early diagnostic and epidemiological investigation.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-224/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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