DENKA COMPANY LIMITED

Denka Company Limited specializes in in vitro diagnostic (IVD) devices focused on measuring low-density lipoprotein (LDL) cholesterol levels. Their portfolio includes spectrophotometry-based LDL cholesterol test kits, as well as calibrators and controls designed for laboratory use. These products help ensure precise quantification of LDL cholesterol in patient samples, supporting clinical decision-making.

Denka Company Limited is headquartered in the United States. The company’s U.S. location aligns with its focus on regulatory compliance and market access for its IVD devices, particularly those listed in the FDA’s Unique Device Identifier (UDI) database.

Denka Company Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their LDL cholesterol IVD products, including kits, calibrators, and controls, ensuring transparency and traceability for healthcare providers and regulatory bodies.

Denka Company Limited’s LDL cholesterol IVD devices are classified as either Class I or Class II under regulatory standards. Class I devices generally pose minimal risk and require less stringent controls, while Class II devices involve moderate risk and may require special controls to ensure safety and performance. The classification depends on factors like the device’s intended use and potential impact on patient health.