MultiSure GCTU
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Basic Information
- Primary DI
- D-47136487613A062
- Basic UDI-DI Code
- B-47136487613A062
- Reference
- S81001, S81002
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The MultiSure GCTU Monitoring System is intended for quantitative measurement of glucose, cholesterol, triglyceride and uric acid level in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for self-testing by individuals at home or for clinical settings by healthcare professional, as an aid in monitoring blood glucose, cholesterol, triglyceride and uric acid level. The MultiSure GCTU system is not intended for diagnosis or screening of diabetes, or for neonatal use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
| W0101060105 | TRIGLYCERIDE TEST STRIPS |
| W0101060102 | CHOLESTEROL TEST STRIPS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W020106019099 | VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2100077-1 | 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).