Maine Standards

LGC Maine Standards is an international in vitro diagnostic (IVD) quality solution manufacturer and service provider. Our goal is to improve the quality of human diagnostics through our vision of Science for a Safer World.

Our market leading Linearity and Calibration Verification VALIDATE® kits cover over 137 analytes across clinical chemistry, immunochemistry, hemostasis and point of care testing. In addition, LGC Maine Standards manufactures private-label quality control, calibrator, and proficiency testing materials, processes specialized biological materials and provides contract quality control and method validation services to the diagnostic, pharmaceutical, CRO and related industries.

LGC Maine Standards’ expertise in developing and stabilizing liquid, multi-constituent, multi-use solutions in human and other biological matrices offers ease and efficiency for end-users and is a valuable resource to IVD and OEM partners. Laboratories inspected by all accreditation organizations, including CAP, JCI, COLA and ISO 15189, successfully use VALIDATE® products to satisfy their linearity and calibration verification requirements.

Located in Cumberland Foreside, Maine, in the U.S.A., our facility is U.S. FDA registered, compliant with the U.S. FDA Quality System Regulation (QSR) and DEA registered for the manufacture of controlled substances. Our facility’s Quality Management System is certified to ISO 13485:2016 by DEKRA Certification B.V.. For further information, please visit: www.mainestandards.com or call +1 (207) 892-1300 to learn more.

Company’s Keywords:

in vitro diagnostics, clinical diagnostic quality materials, clinical chemistry, clinical biochemistry, hemostasis or haemostasis, internal quality controls, external quality controls, proficiency testing, pt or eqa, oem clinical quality materials, liquid stable biological matrices, private lab quality controls, iso 15189, cap & jci accreditation, iso 13485, method validation, calibration verification, linearity testing, assay verification, install kits, correlation kits, ivd quality controls, reference materials, linearity, human diagnostics, us fda quality system regulation