Maxim Biomedical Inc.

Maxim Biomedical is a vertically integrated in vitro diagnostics (IVD) development and manufacturing company with over 20 years of experience serving Fortune 100 companies and U.S. government agencies including the DoD, CDC, and NIH. The company provides end-to-end diagnostic solutions spanning assay development, product engineering, clinical and regulatory strategy, and full-scale manufacturing and fulfillment. Capabilities include antibody screening and conjugation, custom reagent and buffer formulation, lateral flow and ELISA immunoassay development, prototype and pilot-scale production, scalable manufacturing, reagent formulation and dispensing, device assembly and packaging, and in-process and final quality control testing. The company operates an FDA-registered, ISO 13485:2016-certified facility in environmentally controlled cleanrooms (ISO 5/7/8), with biochemistry and dry rooms. Manufacturing specialties include lateral flow, ELISA, and custom immunoassays with branded and private label solutions for retail, clinical, and government channels. Notable achievements include development and manufacturing of the ClearDetect® COVID-19 Antigen Home Test for the NIH RADx initiative and DoD, delivering 22+ million tests to the U.S. government, and a 15+ year partnership supporting Class III, BLA-regulated diagnostic products. The company serves as a contract development and manufacturing organization (CDMO) for diagnostics, supporting partners from early-stage concept through commercialization and sustained production.