36 devices · GMDN 43774
Human chorionic gonadotropin (HCG) alpha-subunit calibrators are laboratory reference materials designed to help validate and standardize diagnostic tests. They provide precise measurements for assays that detect alpha-HCG, a biomarker used in fertility testing, pregnancy screening, and monitoring certain gynecological conditions.
These calibrators are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are supplied as part of assay kits or as standalone reference materials, ensuring accurate results in clinical or research settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.