Eclipse A1C
Basic Information
- Primary DI
- D-47136487600B05F
- Basic UDI-DI Code
- B-47136487600B05F
- Reference
- S54133, S54144, S54145, S54119
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The Eclipse A1c™ Analyzer is intended to be used for the measurement of the percent of Glycohemoglobin (%HbA1c) in capillary (fingerstick) or venous whole blood. It is intended for professional, in vitro diagnostic use and must be used according to the Instructions provided by manufacturer. The Eclipse A1c™ Analyzer could be used in physician offices, laboratories, clinics, hospitals, and could save valuable time in proper control of diabetes. The Diabetes Control and Complications Trial (DCCT) showed the importance of improved glycemic control in reducing the risk and progression of the complications of diabetes. The American Diabetes Association (ADA) recommends measurement of HbA1c level to four times per year, less frequently in patients with stable control.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060101 | GLYCOSILATED HEMOGLOBIN DEVICEs |
| W0101060107 | HBA1C TEST STRIPS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).