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.
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 13485:2003, 21 CFR 820, IVDD 98/79/EC, and CMDCAS. 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.