Release of VALIDATE® D-Dimer for Siemens Sysmex® CS-2500 System analyzers allows clinical laboratories to complete their required D-Dimer linearity and calibration verification and maximize the reportable range while minimizing manual dilutions.
Cumberland Foreside, Maine (PRWEB) July 13, 2017
LGC Maine Standards announces that its VALIDATE® D-Dimer linearity and calibration verification test kit has received US FDA 510 (k) clearance for use on Siemens Sysmex® CS-2500 System analyzers. The VALIDATE® D-Dimer kit, in a human plasma matrix, evaluates D-Dimer. Each VALIDATE® D-Dimer kit, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range for Siemens Sysmex® CS-2500 System analyzers. Each kit is liquid and ready-to-use. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.
Release of VALIDATE® D-Dimer for Siemens Sysmex® CS-2500 System analyzers allows clinical laboratories to complete their required D-Dimer linearity and calibration verification and maximize the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements for linearity and calibration verification under CLIA, CAP, COLA, JCAHO, JCI and ISO 15189.
The addition of VALIDATE® D-Dimer for Siemens Sysmex® CS-2500 System analyzers to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose.
LGC Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis or a laboratory can send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report within five business days.
Contact: Maine Standards Company, LLC
221 US Route 1, Cumberland Foreside, ME 04110
LGC is an international life sciences measurement and testing company with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, calibration verification / linearity testing, genomics reagents and instrumentation, and expert sample analysis and interpretation. LGC serves customers across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Food, Environment, Government and Academia.
LGC’s headquarters are in London and the company employs over 2,000 people, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025, GMP, GLP, ISO Guide 34, ISO/IEC 17043 and ISO 13485:2003.
With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC was privatized in 1996 and is now owned by funds affiliated with KKR. For more information, please visit http://www.lgcgroup.com