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.

Source:

2016 AACC Annual Meeting Press Program

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
You might also like... ×
Cardiovascular disease in COVID-19