105 devices · GMDN 53316
Glycated haemoglobin (HbA1c) IVD reagents are chemical substances designed to work alongside in-vitro diagnostic (IVD) systems for measuring HbA1c levels in blood samples. Clinically, these reagents help assess long-term blood sugar control in patients with diabetes, providing insights for managing the condition over weeks or months.
These reagents are typically regulated as part of IVD systems and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are usually supplied as part of a kit or as standalone components for laboratory use, ensuring accurate and reliable HbA1c testing in clinical settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.