HEALTHYWISER LLC

HealthyWiser LLC specializes in in vitro diagnostic (IVD) products, specifically rapid immunochromatographic test (ICT) kits and clinical-grade IVD devices. Their primary focus is on detecting luteinizing hormone (LH) for point-of-care use in medical settings. These products are designed to deliver rapid results, helping clinicians make timely decisions.

HealthyWiser LLC is based in the United States. As a U.S.-based manufacturer, its devices are regulated under the FDA’s medical device framework. Since their LH IVD products fall under Class I classification, they are subject to FDA requirements for Class I diagnostics, including compliance with UDI listing in the FDA’s Unique Device Identifier database.

HealthyWiser LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of their Class I LH IVD products, aligning with U.S. regulatory standards for medical diagnostics. The UDI system helps track and monitor devices throughout their lifecycle.

HealthyWiser LLC’s LH IVD products are classified as Class I devices. This classification is determined by the FDA based on the risk associated with the device. Class I devices are generally considered to pose the lowest risk and often require less stringent regulatory controls, though compliance with UDI and other applicable FDA requirements still applies.