GlucoSure POC Compact
Basic Information
- Primary DI
- D-47136487603B15Y
- Basic UDI-DI Code
- B-47136487603B15Y
- Reference
- S70466, S70467
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The GlucoSure POC Compact Blood Glucose Monitoring System is intended to automatically and quantitatively measure blood glucose level in venous whole blood, arterial blood, neonatal whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. The GlucoSure POC Compact Blood Glucose Monitoring System is intended for testing outside the body (In Vitro Diagnostics). It is intended for use by near patient and healthcare professionals in laboratories such as physician office laboratories, clinics, and hospitals, as an aid in monitoring blood glucose level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
| W0201060102 | BLOOD GLUCOSE METERS |
| W0101060101 | GLUCOSE TEST STRIPS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).