LGC Maine Standards announces release of VALIDATE® HEPARIN calibration verification / linearity test kit for IL ACL TOP® 500 hemostasis test systems
LGC Maine Standards is pleased to announce our VALIDATE® HEPARIN calibration verification / linearity test kit has received US FDA 510(k) clearance for use on Instrumentation Laboratory ACL TOP® 500 hemostasis test systems.
The VALIDATE® HEPARIN kit evaluates Heparin Anti-Xa activity in a human plasma matrix. Each VALIDATE® HEPARIN kit is prepared using CLSI’s EP06-A 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 using Instrumentation Laboratory ACL TOP® 500 hemostasis test systems to complete their required Heparin calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions. The addition of VALIDATE® HEPARIN to the LGC Maine Standards expanding 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 one hundred analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Coagulation and Whole Blood.
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.