Eclipse PLUS
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Basic Information
- Primary DI
- D-47136487608B06P
- Basic UDI-DI Code
- B-47136487608B06P
- Reference
- S35010
- 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 PLUS Multi-Purpose Analyzer is intended to be used for automated and quantitative measurements to monitoring the concentration of Glycohemoglobin (HbA1c) in capillary (fingerstick) or venous whole blood; and Microalbumin, Creatinine and Albumin/ Creatinine Ratio (ACR) in urine. The testing result aids in monitoring glycohemoglobin level in diabetes mellitus and detection of patients at risk for nephropathy. It is intended for in vitro diagnostic performed by healthcare professionals in physician offices, laboratories, clinics and hospitals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010106020601 | URINE TESTING CONTROLS |
| W0101060201 | URINE SINGLE TEST STRIPS (INCL. TABLETS) |
| W0102160101 | ALBUMIN INCL. UALBUMIN RT & POC |
| W0102160102 | GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC |
| W020106019099 | VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER |
Similar Devices
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