VIDAN DIAGNOSTICS, LLC

Vidan Diagnostics, LLC specializes in in vitro diagnostic (IVD) devices focused on metabolic monitoring. Their products include glucose test strips (using electrometry), ketone (acetoacetate) reagent-based tests, and point-of-care systems that simultaneously measure blood glucose and ketone levels. These devices are designed for both clinical and home-use settings to help track metabolic health indicators like diabetes management.

Vidan Diagnostics, LLC is based in the United States, which means its devices are subject to FDA regulation under the In Vitro Diagnostic Device (IVD) framework. Since the company operates within the U.S., its products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring compliance with domestic regulatory requirements for traceability and transparency.

Vidan Diagnostics’ devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory standards. The UDI system helps healthcare providers and regulators verify device details, including manufacturer information and classification.

Vidan Diagnostics’ devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require general controls for regulation, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential health impact, and the level of monitoring required during use.