Validate

Linearity and calibration verification kits for human diagnostic analyzers.
VALIDATE® ready-to-use kits are designed to assist in the documentation of linearity, calibration verification and verification of linear range required by many inspection agencies.   VALIDATE® will also provide assistance when troubleshooting instrument systems, reagent problems and calibration anomalies.  Multiple product configurations are available to meet the different needs of the many instrument systems available.  Configurations are specifically formulated to maximize reportable ranges with minimum dilutions.

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.