About - Lin-Zhi International, Inc.

What We Do

Lin-Zhi International, Inc. (LZI) is a manufacturer of in-vitro diagnostic reagents for urine and oral fluid screening for the detection of drugs of abuse. All research and development of assays are done in-house. LZI has FDA 510(k) clearance on most of the Homogeneous Enzyme Immunoassay tests that are for sale and sells the associated calibrators and controls for each test. Also available for purchase are the universal negative calibrator and Multi-Analyte calibrators and controls. The Research and Development team is currently optimizing the oral fluid enzyme immunoassays and their associated calibrators and controls, as well as working on additional urinalysis assays.

Mission Statement

Lin-Zhi International, Inc.’s pledge to our customers is to deliver high quality in vitro diagnostic medical devices that meet or exceed their expectations. We strive to provide qualified technical support and attentive, professional customer service. There are several business aspects that play a role into the company including the manufacturing process, products, quality control, and customer interactions. All those aspects are required to be first rate, supplemented with thorough, traceable documentation, and produced under good manufacturing processes (GMP), ISO 13485:2016 (International Organization for Standardization for medical device quality management system requirements), 21 CFR 820 (quality system regulation for medical devices), the European Union’s In Vitro Diagnostic Directive IVDD 98/79/EC, and Canadian Medical Devices Regulation (SOR/98-282). Since the medical device industry is well regulated, the safety and efficacy of our Quality Management System (QMS) and devices are high priority. In conclusion, as part our commitment to excellence, we seek to continually improve our QMS and products.

Commitment to Excellence

All projects are thoroughly documented and materials and products are easily traceable. There are multiple levels of review throughout the production process, including before and after the project is completed. There are continuous internal audits of the manufacturing, business, and R&D processes completed by the regulatory team, as well as audits done by outside authorities each year. Quality Assurance is also performed through complaint handling and customer feedback.

Lin-Zhi International is DEA registered, has FDA 510(k) clearance on most assays, follows Good Manufacturing Process, and has many certifications including ISO 13485:2016, MDSAP, and CE. Our products are manufactured by trained professionals who adhere to the most rigorous standards in order to keep our products at the highest quality possible. The Quality Control team ensures all products are only of the highest performance quality before shipping to customers.

Company History

Lin-Zhi International, Inc. was founded by Dr. Cheng-I Lin in 1998. Dr. Marie Lin became President and CEO of the company in 2004. Lin-Zhi International, Inc. is run by people who are passionate about providing the highest quality in-vitro diagnostic reagents to customers all over the world.