Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
QUIK-CHECK Ultra Total Cholesterol Test Strips
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-C131-5017SV
- Basic UDI-DI Code
- B-C131-5017SV
- Reference
- C131-5017
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The QUIK-CHECK Ultra Total Cholesterol Test Strips are intended to use with QUIK-CHECK Ultra Cholesterol Meter for the quantitative determination of Total Cholesterol in fresh fingertip capillary whole blood as an aid in diagnosis of atherosclerotic coronary artery disease and metabolic disorders involving lipids and lipoproteins. The QUIK-CHECK Ultra Total Cholesterol Test Strips is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060102 | CHOLESTEROL TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
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