Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
LYHER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06972412611256
- Basic UDI-DI Code
- B-06972412611256
- Reference
- 303051
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Laihe Biotech Co., Ltd.
Additional Description
The LYHER® COVID-19 and Influenza A/B Antigen Test Kit for self-testing is an in vitro immunoassay. The assay is for the direct and qualitative detection of antigen of SARS-CoV-2 and Influenza A/B from nasal swab. The kit is for in vitro diagnostic use by non-professionals only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099004 | INFLUENZA A AND /OR B - RT & POC |
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/068/W/E.2 | CeCert Sp. z o.o. | Expired |
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