Mission Cholesterol Monitoring System
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Basic Information
- Primary DI
- D-C111-2011QS
- Basic UDI-DI Code
- B-C111-2011QS
- Reference
- C111-2011
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The Mission Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol (CHOL), High-Density Lipoprotein (HDL), and Triglycerides (TRIG) in capillary and venous whole blood, serum and plasma. The value of Low-Density Lipoprotein (LDL) and the ratio of CHOL/HDL are calculated by the Mission Cholesterol Meter. The Mission Cholesterol Monitoring System consists of Mission Cholesterol Meter, Mission Cholesterol Test Devices and Mission Cholesterol Control Solution, and it is for self-testing and professional use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 042074 0026 | TÜV SÜD Product Service GmbH | Expired |
Similar Devices
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