Canadian Biotech Limited develops and manufactures rapid diagnostic solutions through a cross-continental model that pairs Canadian R&D oversight and materials with high-volume production in Dar es Salaam, Tanzania. Its flagship CheckFor® brand serves healthcare providers with professional-grade tests, while proprietary manufacturing technology and integrated tracking support large-scale public-health procurement. The company works with governments, NGOs, and medical distributors seeking accessible diagnostics for African and global markets.
ISO Standards Adherence
Compliance program
Maxim Biomedical, IncFrom its Rockville, Maryland facility, Maxim Biomedical develops and manufactures diagnostic tests while helping healthcare companies and government agencies move assays from concept to commercial production. Founded more than 20 years ago, the family-led company produces millions of tests each month in an FDA-registered, ISO 13485:2016-certified operation with capacity exceeding 15 million devices monthly. Its own products include HIV surveillance assays and the ClearDetect COVID-19 Antigen Home Test, alongside contract development and manufacturing for partners worldwide.ROCKVILLE, MD
Chembio Diagnostic Systems, IncChembio Diagnostic Systems, a Medford, New York subsidiary of Biosynex, develops and manufactures rapid point-of-care diagnostic tests for detecting and monitoring disease. Its proprietary Dual Path Platform (DPP®) technology supports simple tests that can use a small blood sample and deliver results in about 15 minutes, including the FDA-approved, CLIA-waived DPP® HIV-Syphilis test. Chembio serves clients worldwide through offices and partners and also applies its diagnostic platform to veterinary testing.MEDFORD, NY
First Diagnostic CorporationFirst Diagnostic Corporation develops rapid point-of-care diagnostic systems and helps other medical-device manufacturers bring diagnostic technologies to the U.S. healthcare market. Founded in 2004 as a medical-device manufacturer, the privately held company now combines its own rapid-test brands with sales representation, distribution, marketing, and customer support for partner manufacturers. Its eight-person operation maintains government and military program relationships and cites GMP and ISO 9001 quality standards.NEW YORK, NY
Randox LaboratoriesRandox Laboratories develops and manufactures in vitro diagnostic products and laboratory solutions, spanning quality-control materials, analysers, reagents and genomic services. With more than 40 years of experience, the company also provides contract manufacturing and companion-diagnostic support, serving customers through facilities and laboratories across the UK, Europe, Asia and the USA. Its proficiency-testing programmes reach more than 100,000 users in over 145 countries, while its manufacturing operations have capacity exceeding 10.5 million litres per year.KEARNEYSVILLE, WV