Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
SARS-COV-2 Antigen Rapid Tests for Self-Testing
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06921807602942
- Basic UDI-DI Code
- B-06921807602942
- Reference
- CG3625
- Device Types
-
Single use Sterilization
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Beijing Lepu Medical Technology Co., Ltd.
Additional Description
This product is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs that are self-collected by an individual aged 18 years or older or are collected by an adult from an individual younger than 18 years old. This test is intended for use in individuals with symptoms or other epidemiological reasons to suspect a COVID-19 infection
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040604 | INFLUENZA & PARA INFLUENZA |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2062714-1 | TÜV Rheinland LGA Products GmbH | Expired |
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