VALIDATE D-Dimer kit from LGC Maine Standards receives US FDA approval for use on hemostasis test systems

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.