Eclipse PLUS

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.

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).