Maine Standards
Medical DeviceMaine, United States11-50 Employees
LGC Maine Standards is a medical equipment manufacturer and service provider based in Cumberland Foreside, Maine, focused on in vitro diagnostic quality solutions. It develops and supplies quality control materials, calibrators, proficiency testing materials, and contract quality control and method validation services for diagnostic laboratories, pharmaceutical companies, CROs, and related industries. Its VALIDATE line includes linearity and calibration verification kits that cover more than 137 analytes across clinical chemistry, immunochemistry, hemostasis, and point-of-care testing. The company also produces private-label QC materials and calibrators, and formulates specialized biological materials and multi-use solutions designed to support end-users and IVD OEM partners. Operations are regulated to standards including FDA Quality System Regulation, ISO 13485:2016, and accreditations from CAP, JCI, COLA, and ISO 15189, with DEA registration for controlled substances. By providing both materials and services, LGC Maine Standards positions itself within the international IVD quality solutions ecosystem, supporting safer diagnostics through its technical capabilities.
1-888-653-2347 
support@leadiq.com 
