LGC Maine Standards is an in vitro diagnostic manufacturer of VALIDATE® linearity and calibration verification test kits, covering over 150 analytes across clinical chemistry, immunochemistry, hemostasis and point of care. In addition, LGC Maine Standards manufactures private-label quality controls, calibrators, and proficiency testing solutions, 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 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.. LGC Maine Standards’ goal is to improve the quality of human diagnostics through our vision of Science for a Safer World.
For further information, please view our online publications below, or contact us.
Publications
VALIDATE® Product Brochure
VALIDATE® Product Offering Sheets
CHEMISTRY
ABBOTT ARCHITECT/ALINITY
BECKMAN COULTER AU
BECKMAN COULTER DXC 700 AU
BECKMAN COULTER UNICEL® DXC SYNCHRON® & DXI ACCESS®
ORTHO VITROS®
ROCHE COBAS®
SIEMENS ADVIA®
SIEMENS ATELLICA®
SIEMENS DIMENSION®
SIEMENS DIMENSION VISTA®
HEMOSTASIS
INSTRUMENTATION LABORATORY ACL TOP®
SIEMENS SYSMEX
STAGO STA®