Boditech Med, Inc.

Boditech Med, Inc. specializes in in vitro diagnostics (IVDs), primarily for laboratory and point-of-care settings. Their product range includes reagents like thyroid stimulating hormone (TSH), faecal occult blood, and C-reactive protein (CRP) tests, as well as nucleic acid extraction kits and immunoassay analysers. They also produce semi-automated analysers for CRP and faecal occult blood testing, rapid antigen tests for SARS-CoV-2 (including self-testing kits), and specimen processing instruments. These devices are designed for both clinical and home-use applications.

Boditech Med, Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the company operates within the U.S., its products are subject to FDA pathways such as 510(k) clearances and the Unique Device Identifier (UDI) system. The FDA’s regulatory databases, like the 510(k) and UDI registries, list these devices, ensuring compliance with U.S. medical device regulations.

Boditech Med, Inc.’s devices are listed in the FDA’s official regulatory databases, specifically the 510(k) premarket notification clearance registry and the Unique Device Identifier (UDI) system. These registries document the authorisation status of their Class I and Class II devices, ensuring transparency and compliance with U.S. medical device regulations.

Boditech Med, Inc.’s devices are classified under two main FDA categories: Class I and Class II. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body system it interacts with, as outlined in the FDA’s regulatory framework.

Boditech Med, Inc. manufactures self-testing devices for home use, including rapid antigen tests for SARS-CoV-2 (such as the Swab-N-Go Home Test COVID-19 Ag). These products are designed for point-of-care or at-home diagnostic testing, allowing individuals to perform tests without needing a clinical laboratory. The company’s home-use devices are still subject to FDA regulatory pathways to ensure safety, performance, and compliance.