Eu Ivdd
Eu Ivd Self Testing
On The Market
🇹🇼 Taiwan
HemoSmart GOLD
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487606AHS2D
- Basic UDI-DI Code
- B-47136487606AHS2D
- Reference
- S5800112Â
- 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 HemoSmart GOLD Hemoglobin Screening System using a testing solution with a known range of potassium hexacyanoferrate, which is the reactive substance in hemoglobin. 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.
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 | TÃœV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇬🇷 Greece
🇫🇮 Finland
🇵🇱 Poland
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