Newswise — CUMBERLAND FORESIDE, Maine – LGC Maine Standards is pleased to announce our VALIDATE® D-Dimer calibration verification / linearity test kit has received US FDA 510(k) clearance for use on Instrument Laboratory ACL TOP® hemostasis test systems. The VALIDATE® D-Dimer kit evaluates D-Dimer in a human-plasma base matrix. Each VALIDATE® D-Dimer kit is prepared using the CLSI recommended "equal delta" method for linearity testing and is liquid, ready-to-use. Simply add the product from the dropper bottle directly into a sample cup and run in replicates.
Release of this product will allow clinical laboratories to complete their required D-Dimer calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The addition of VALIDATE® D-Dimer to the LGC Maine Standards portfolio of products demonstrates a continued commitment to manufacture high-quality calibration verification / linearity products that meet industry needs.
LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE® calibration verification / linearity test kits for over ninety analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Prostate Specific Antigen, Anemia, Fertility, and D-Dimer.
LGC Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis or, in the United States, 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.
About LGC 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 designated UK National Measurement Institute for chemical and bio measurement. LGC was privatised in 1996 and is now owned by funds affiliated with KKR.
For more information, please visit www.lgcgroup.com
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