SCI Medic, Inc.

SCI Medic, Inc. specializes in in-vitro diagnostic (IVD) kits designed to detect human chorionic gonadotropin (hCG) in clinical settings. These include rapid immunochromatographic test (ICT) kits, such as the NEW CHOICE PLUS, NEW CHOICE, and UCHECK, which are primarily used for point-of-care pregnancy testing. The devices are intended to provide quick results—typically within minutes—to help confirm or exclude early pregnancy in clinical environments.

SCI Medic, Inc. is based in the United States. As a US-based manufacturer, its devices must comply with FDA regulations, including the Unique Device Identification (UDI) system. The company’s products are listed in the FDA’s UDI database, which is a mandatory requirement for medical devices in the US to ensure traceability and regulatory oversight.

SCI Medic, Inc.’s devices are classified as Class II under US regulations. This classification is typically assigned to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices require authorisation through the FDA’s UDI system, which helps track and monitor their use in clinical settings.

SCI Medic, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system is a mandatory requirement for medical devices in the US, ensuring each product has a unique identifier for tracking, traceability, and regulatory compliance. Listing in this database helps healthcare providers and regulators verify the device’s identity and compliance status.

The primary purpose of SCI Medic, Inc.’s hCG detection kits, such as the NEW CHOICE and UCHECK, is to provide rapid, point-of-care testing for human chorionic gonadotropin (hCG) in clinical environments. These kits are designed to deliver results within minutes, enabling healthcare providers to quickly confirm or exclude early pregnancy. This supports timely clinical decision-making, particularly in urgent or outpatient settings where immediate results are beneficial.