Maine Standards Company receives FDA clearance for VALIDATER FERRITIN calibration verification/linearity test kit

Maine Standards Company, LLC has received 510(k) clearance for its VALIDATE FERRITIN calibration verification/linearity test kit. The VALIDATE FERRITIN kit contains Ferritin in a human-serum base matrix. Each VALIDATE FERRITIN kit contains five levels prepared using the CLSI recommended “equal delta” method for linearity testing. The test kits are liquid and ready to use: Add the product from the dropper bottle directly into a sample cup and run as a patient sample in duplicate or triplicate. Clearance of this product will allow clinical laboratories to complete their required Ferritin calibration verification/linearity testing and maximize the reportable range while minimizing manual dilutions.

Maine Standards Company, LLC manufactures VALIDATE calibration verification/linearity test kits for more than eighty analytes, including general chemistries, urine chemistries, enzymes, lipids, therapeutic drugs, cardiac markers, thyroids, serum proteins, vitamin D and prostate specific antigen. VALIDATE FERRITIN addresses the growing demand by laboratories for a product to document calibration verification/linearity of their testing system.

In addition, Maine Standards Company’s MSDRx data reduction software is also available at no charge for real time data analysis or, in the United States, a laboratory can send its data to Maine Standards Company, where a technical specialist will complete the data analysis and return a report within five business days. Learn more about the VALIDATE products.