Randox 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.
ISO 13485
certification
ISO/IEC 17043
certification
ISO 15189
certification
ISO 27001
certification
IVDD 98/79/EC; transitioning toward IVDR
compliance_program
FDA MDSAP CFR T21 Part 820 Compliant
compliance_program
GCP Certified
certification
LGC Clinical DiagnosticsLGC Clinical Diagnostics manufactures quality measurement tools, biological materials and reagent components that help laboratories and diagnostic developers validate assays and produce reliable results. Part of LGC Group, it brings together five IVD quality-control manufacturers with The Native Antigen Company, whose infectious-disease antigens and antibodies support research into emerging diseases. The business serves more than 20,000 customers in over 100 countries and has more than 35 years of industry experience.EDGEWOOD, NY
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
SCHOTTFor more than 140 years, SCHOTT has developed and manufactured specialty glass, glass-ceramics and other material solutions for demanding applications ranging from optics and health to electronics and energy. The Germany-based group operates production and sales units in more than 30 countries, combining glass expertise with analytical, consulting and contract manufacturing services. Its SCHOTT MINIFAB operations provide end-to-end development and manufacturing of in-vitro diagnostic consumables, supported by ISO-certified quality systems.327212DURYEA, PA
Gold Standard Diagnostics HorshamFor more than 20 years, Gold Standard Diagnostics Horsham has developed and manufactured rapid test systems for environmental, food and life-sciences testing. Formerly Abraxis, the Horsham operation became part of Eurofins Technologies in 2017 and adopted the Gold Standard Diagnostics name in 2022. Its U.S.-based scientific team develops customized assays and contract-manufacturing programs, serving customers directly or through distributors in more than 100 countries under ISO 9001:2015 and ISO 13485:2016-certified quality systems.325413HORSHAM, PA