FDA Product Code QRL: Multiple Use Blood Lancet For Single Patient Use Only

Repeated blood sampling is essential in diabetes management and chronic disease monitoring. FDA product code QRL covers multiple-use capable blood lancets intended for single-patient use over multiple sessions.

Unlike strictly single-use lancets, these devices are designed to allow the same patient to reuse the lancet across multiple lancing events for capillary blood sampling, reducing waste and cost in patients requiring frequent glucose monitoring or other point-of-care testing.

QRL devices are Class II medical devices, regulated under 21 CFR 878.4850 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Facet Technologies, LLC, Tianjin Huahong Technology Co., Ltd. and Roche Diabetes Care, Inc..