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VALIDATE® Human Diagnostic Linearity and Calibration Verification Kits
VALIDATE® PRODUCTS ARE SYNONYMOUS WITH EFFICIENCY AND QUALITY.
READY-TO-USE LINEARITY SETS: Liquid samples require no reconstitution. Simply add product to your sample cup and run in replicates.
MULTIPLE PRODUCT CONFIGURATIONS: LGC Maine Standards specifically formulates its VALIDATE® product line into specialized configurations with different analyte concentrations that challenge your analyzers' full reportable range.
EASY-TO-USE FOR RETESTING OR TROUBLESHOOTING: With long open-vial stability, you'll have adequate product for repeats or troubleshooting. These are unique samples to have available for troubleshooting, since VALIDATE® products challenge your full reportable range. EQUAL-SPACED LEVELS: Levels 1 through 5 are prepared to create “equal deltas” as recommended by the CLSI EP06-A guideline for linearity and calibration verification.
TWO TESTING CYCLES FOR ONE INSTRUMENT: We will provide adequate product volume to complete two linearity and calibration verification cycles.
ISO CERTIFIED: Our facility's Quality Management System is certified to ISO 13485:2016 by DEKRA Certification B.V.
U.S. FDA REGISTERED FACILITY: Our facility is registered with the U.S. FDA and complies with the U.S. FDA Quality System Regulation (QSR).
DEA REGISTERED FACILITY: Our facility is registered by the U.S. Drug Enforcement Administration for the manufacture and analytical laboratory testing of Schedule 1 - 5 controlled substances.
VALIDATE® PRODUCTS ARE CE MARKED: Check with international distributors for specific product availability.
ACCREDITATION REQUIREMENTS: Use of VALIDATE® products, while augmenting daily QC, assists with fulfilling various quality control requirements - such as Analytical Measurement Range (AMR) and Clinically Reportable Range (CRR) - for linearity and calibration verification under CLIA '88, CAP, COLA, JCAHO, JCI and ISO 15189.
LGC Maine Standards - Providing More
You can always depend on LGC Maine Standards to make your job easier. We understand the demands of clinical laboratories, and we are committed to providing you with outstanding customer service. Working with us is always a guarantee of responsive service. Too often customer service and support means listening to a recorded message or waiting for answers that never come. When you call LGC Maine Standards, you reach a knowledgeable, friendly person ready to help you. LGC Maine Standards' experts are qualified laboratory professionals with clinical laboratory experience. Our unparalleled technical support staff is familiar with all VALIDATE® products, data reduction reports, and a wide range of analyzers, as well as linearity and calibration verification requirements and regulations of inspection agencies. For more information visit www.mainestandards.com or call +1 (207) 892-1300.