Wellion AMADEUS
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Basic Information
- Primary DI
- D-47136487603C3SY3
- Basic UDI-DI Code
- B-47136487603C3SY3
- Reference
- S5800475, S5800476, S5800477
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The purpose of the control solution test is to validate the performance of the blood glucose monitoring system. There are 2-3 different levels of control solution. Each has a different concentration of glucose, allowing you to check for test result accracy at low, normal and high glucose levels for any given batch of test strips. Results that are within the specified glucose concentration ranges confirm that the user's technique is appropriate and that the test strip and the meter are functioning properly. The blood glucose monitoring system used together with the control solution is plasma calibrated.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÜV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).