Sakar International, Inc.

Sakar International, Inc. primarily manufactures two main categories of medical devices: rapid immunoassay kits and clinical test devices for detecting multiple drugs of abuse in intravenous diagnostic (IVD) formats. Additionally, the company produces air-conduction hearing aids, including behind-the-ear (BTE) and receiver-in-canal (RIC) models, under branded product lines like Brookstone and THE SOLUTION.

Sakar International, Inc. is based in the United States. As a manufacturer operating in this jurisdiction, the company adheres to the regulatory requirements set by the U.S. Food and Drug Administration (FDA) for the devices it produces, including classification and listing in relevant databases.

Sakar International, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for regulatory and clinical purposes.

Sakar International, Inc.’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.

The rapid immunoassay kits and clinical test devices manufactured by Sakar International, Inc. are designed to detect multiple drugs of abuse in IVD formats. These tests are used in clinical settings to quickly and accurately identify the presence of substances like opioids, stimulants, or other controlled compounds, aiding in patient assessment, treatment planning, and compliance monitoring.