Plasma protein IVD, calibrator

Plasma protein IVD calibrators are reference materials designed to provide standardized measurements for assays that quantify specific proteins in plasma samples. Clinically, they ensure accuracy and consistency in diagnostic tests for conditions like immune disorders, liver disease, or protein deficiencies by defining precise benchmarks for comparison.

These calibrators are typically regulated as in vitro diagnostic (IVD) devices, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are usually supplied as liquid or lyophilized reagents, intended for single-use in laboratory settings to maintain traceability and reliability in clinical testing workflows.