The Validate Ferritin calibration verification and linearity test kit from Maine Standards Company, Cumberland Foreside, Me, has received 510(k) clearance. Each liquid, ready-to-use kit contains Ferritin in a human-serum base matrix and includes five levels prepared using the CLSI-recommended “equal delta” method for linearity testing. Users can add the product from the dropper bottle directly into a sample cup and run as a patient sample in duplicate or triplicate. According to the company, clearance of this product allows clinical laboratories to complete their required Ferritin calibration verification and linearity testing and to maximize the reportable range while minimizing manual dilutions. For more information, visit Maine Standards Company.
Calibration Verification and Linearity Test Kit
