Device Dossier

Clinical chemistry substrate IVDs

Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Sebia). ARTG record, intended purpose,…

Intended purpose

The Sebia Hb A1c Kit is designed for the separation and quantitative determination of glycated haemoglobin (HbA1c) in a clinical specimen by capillary electrophoresis using a Sebia Capillary Electrophoresis instrument.

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