About Ark Diagnostics, Inc.

About Us

ARK Diagnostics Inc. designs, manufactures, and distributes in vitro diagnostic products. ARK’s proprietary assays accurately measure drug levels in biological fluids. Clinicians use these measurements to guide dosing decisions for safe, effective, and personalized drug therapy. By optimizing drug levels, clinicians improve outcomes, reduce toxicity, and lower healthcare costs. ARK is dedicated to improving the quality of patient health through better therapeutic drug management.

ARK’s quality management system is certified to ISO 13485:2003 and the Canadian Medical Devices Conformity Assessment Scheme (CMDCAS). The company is committed to quality compliance through its strong management principles and carefully follows Good Manufacturing Practices.

From conception to commercialization, ARK uses its unique blend of scientific expertise and deep industry knowledge to deliver high-quality assays for new generations of drugs. Its highly regarded homogeneous enzyme immunoassay technology is adaptable to a wide variety of automated clinical chemistry analyzers. Proprietary projects for kitted products and OEM projects are engaged.

Founded in 2003, ARK Diagnostics, Inc. is a privately held company in Fremont, California.