Sugentech Inc._Osong Branch

Sugentech Inc. specializes in in-vitro diagnostic (IVD) devices, primarily rapid immunoassay tests for clinical and home use. Their portfolio includes kits and tests for detecting luteinizing hormone (LH) and human chorionic gonadotropin (hCG), such as pregnancy and ovulation tests. They also produce biological fluid specimen capillary collectors for blood sampling and immunoassay reagent vehicles, which assist in reading test results. These devices are designed for both clinical and point-of-care settings.

Sugentech Inc. has an Osong branch operating under US regulatory oversight, meaning their devices are subject to the FDA’s In Vitro Diagnostic Device Regulations. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with US traceability and regulatory requirements. This ensures their devices meet applicable standards for safety, performance, and quality within the US market.

Sugentech Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for traceability, compliance tracking, and regulatory transparency. The UDI system helps healthcare providers, regulators, and manufacturers maintain accurate records of medical devices in circulation.

Sugentech Inc.’s devices fall under two classification categories: Class I and Class II, as defined by the FDA’s In Vitro Diagnostic Device Regulations. Class I devices generally pose minimal risk and 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 factors like the device’s intended use, potential harm, and the nature of its diagnostic purpose.

Sugentech Inc. develops a range of IVD tests for fertility and menopause monitoring, including rapid immunoassay kits for detecting luteinizing hormone (LH) and human chorionic gonadotropin (hCG). Their portfolio includes digital and strip-based pregnancy tests, ovulation tests, and a menopause test, as well as capillary blood collection tools for specimen collection. These devices are designed to provide accurate, timely results for clinical or home use, supporting reproductive health tracking.