Full blood count IVD, reagent

Full blood count (FBC) reagents are laboratory chemicals designed to work with in vitro diagnostic (IVD) systems for analyzing whole blood samples. Clinically, they enable the measurement of key blood parameters like red and white blood cell counts, hemoglobin levels, and platelet counts—critical for diagnosing conditions such as anemia, infections, or blood disorders.

These reagents are typically regulated as part of IVD systems, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are usually supplied as kits or components for use in automated hematology analyzers, with classification depending on the jurisdiction and specific device combination. Always check local regulations for supply and use requirements.