7-ELEVEN, INC.

7-ELEVEN, INC. specializes in rapid in vitro diagnostic (IVD) kits that detect human chorionic gonadotropin (hCG) in clinical settings. These tests are specifically designed for early pregnancy detection and are intended for use in point-of-care environments, providing immediate results. The focus is on rapid, user-friendly diagnostic solutions for healthcare providers.

7-ELEVEN, INC. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes its listed devices, ensuring traceability and compliance with U.S. regulatory requirements for medical devices.

The devices produced by 7-ELEVEN, INC. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring transparency and compliance with regulatory standards for Class II devices.

The devices manufactured by 7-ELEVEN, INC. fall under the classification of Class II. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as pregnancy test kits designed for clinical use.