Rediston Limited

Rediston Limited specializes in in vitro diagnostic (IVD) devices focused on blood glucose and ketone monitoring. Their products include test strips for measuring blood glucose and ketone levels, reagent kits for electrometry-based testing, and a home-use clinical chemistry system designed for monitoring multiple analytes. These devices are primarily intended for point-of-care and consumer use, particularly in diabetes management and metabolic monitoring.

Rediston Limited is based in the United States. Their devices are manufactured and intended for use within the U.S., where they must comply with applicable FDA regulations for in vitro diagnostics, including performance and safety standards.

Rediston Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under FDA oversight, helping healthcare providers and regulators identify and verify the devices in use.

Rediston Limited’s IVD devices fall under the FDA’s Class II regulatory category. This classification indicates that while the devices pose moderate risk, they require special controls beyond general controls to ensure their safety and effectiveness. Class II devices undergo additional scrutiny, including performance testing and labeling requirements, to mitigate potential risks.