Maxim Biomedical, Inc.
Biotechnology ResearchMaryland, United States11-50 Employees
At MaximBio, we partner with diagnostics and life science organizations to develop, analytically validate, and manufacture scalable immunoassays, LFAs, and ELISA platforms designed for regulatory and commercial success. With 20+ years of experience in immunoassay development and manufacturing, we deliver end-to-end support across lateral flow, ELISA, and custom diagnostic platforms - from early feasibility through full-scale production. Our approach is built around designing for manufacturability and regulatory readiness from day one, reducing downstream risk and accelerating time to market for both emerging innovators and established diagnostics leaders. Innovation & Technical Expertise • Advanced chemistry and reagent design across lateral flow and ELISA platforms • Rapid feasibility, prototyping, and verification workflows • Assay development aligned to scale-up, transfer, and commercialization requirements Quality & Compliance • FDA cGMP registered for medical device manufacture and distribution • Compliant with 21 CFR Part 820 • ISO 13485:2016 certified for manufacturing and packaging of medical devices • Proven track record: >99.99% acceptance rate for tests developed and manufactured under U.S. government COVID response programs Scalable, Flexible Manufacturing in the United States MaximBio combines high-volume capacity - 15+ million devices per month - with the flexibility to support small-batch prototyping, validation builds, and clinical production. Our vertically integrated, U.S.-based infrastructure enables strong supply chain control, rapid iteration, and dependable commercial execution. Our Commitment We operate as a long-term development and manufacturing partner, focused on technical rigor, regulatory alignment, and operational excellence. When product performance, quality, and delivery timelines matter, MaximBio provides the structure, scale, and scientific depth to move programs forward with confidence.
1-888-653-2347 
support@leadiq.com 
