Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
COVID-19 Antigen Nasal Test Kit
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 06952804808150
- Basic UDI-DI Code
- B-06952804808150
- Reference
- COV-S35002H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
Additional Description
The COVID-19 Antigen Nasal Test Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleocapsid protein from nasal secretions. This test is intended for professional use Test results should not be used as a sole basis for diagnosis but should always be interpreted by a physician in the clinical context.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-078/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇩🇪 Germany
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