Eu Ivdd
Eu Ivd Self Testing
On The Market
๐น๐ผ Taiwan
UASure II
Devices (same UDI-DI)
1
Certificates
1
Countries
4
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487605AUS3D
- Basic UDI-DI Code
- B-47136487605AUS3D
- Reference
- S5800386
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- 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 uric acid system using a testing solution with a known range of uric acid. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly. The 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) | HL 2100077-1 | TรV Rheinland LGA Products GmbH | Expired |
Available In Countries
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ซ๐ท France
๐ต๐ฑ Poland
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