Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
COVID-19 Antigen Rapid Test
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- D-ISCOVu005G
- Basic UDI-DI Code
- B-ISCOVu005G
- Reference
- ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Clongene Biotech Co., Ltd.
Additional Description
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab from individuals with symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is intended for self-use by lay person.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-017/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇭🇺 Hungary
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