CERA-STAT™ 2000 Analyzer

Primary DI

08800065164004

Basic UDI-DI Code

B-08800065164004

Reference

CS200M10

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GC MEDIS Corp.

CERA-STAT™ 2000 Analyzer is an in vitro diagnostic, Point Of Care (POC) device for professionals only who measure hemoglobin A1c in hospitals, clinical centers, and laboratories. Hemoglobin A1c is often called HbA1c, which is the combination of glucose and hemoglobin that carries oxygen in the red blood cells. Hemoglobin A1c is the glucose ratio in the blood and reflects the average glucose level over 2 to 3 months, therefore it is useful and a precise factor in long-term glucose level management. Estimated average glucose(eAG) is a term you may not be familiar with. The American Diabetes Association (ADA) has introduced this term to help you translate HbA1c tests into numbers that would more closely represent daily glucose meter readings. CERA-STAT™ 2000 Analyzer is one of point-of-care diabetes analyzers available that can provide the eAG result, in addition to the HbA1c result, allowing for easier diabetes care.

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