Prescription Use Blood Glucose Meter For Near-Patient Testing

PZI is the FDA product code for Prescription Use Blood Glucose Meter For Near-Patient Testing, a class II device type, regulated under 21 CFR 862.1345. FDA's definition for this code reads: "Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia". As of 2026-09-10, FDA records hold 14 510(k) clearances under this code, the most recent dated 2026-06-12, and one recall.