Hematology— FDA advisory panel HE

Hematology covers the blood-testing backbone of the clinical laboratory: automated cell counters and hematology analyzers, coagulation analyzers and their reagent systems, blood-collection tubes and lancets, centrifuges, and point-of-care coagulation monitors such as INR self-testing meters. Its product codes skew toward reagent-and-instrument systems, so — as with clinical chemistry — the cleared "device" is frequently an assay kit tied to a named platform.

Point-of-care coagulation is the panel's most patient-visible corner: warfarin self-monitoring pushed INR meters into homes, and the panel's clearance record tracks that migration. Note the jurisdictional boundary that shapes what's missing here: blood-bank products — blood grouping reagents, donor-screening tests — are largely regulated by FDA's biologics center (CBER), so the transfusion side of hematology is thinner in this data than clinical reality would suggest.