Maine Standards Company, LLC Receives FDA Clearance for VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit

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VALIDATE® FERRITIN will address the growing demand by laboratories fora product to document calibration verification/linearity of their testing system.

Maine Standards Company, LLC announced that it 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. Simply 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. The addition of VALIDATE® FERRITIN to the Maine Standards Company portfolio of products demonstrates a continued commitment to manufacture calibration verification / linearity products that meet industry needs.

Maine Standards Company’s 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 Maine Standards Company where a technical specialist will complete the data analysis and return a report within five business days.

About Maine Standards Company

Maine Standards Company is located in Cumberland Foreside, Maine and manufactures VALIDATE® calibration verification / linearity test kits for over eighty analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D and Prostate Specific Antigen. Personnel at Maine Standards Company are dedicated to providing the highest quality materials and the best customer service in the industry. Maine Standards Company’s goal is to help clinical laboratories easily validate and maximize reportable ranges while minimizing manual dilutions. The Quality System for Maine Standards Company is registered to ISO 13485:2003. For further information, please visit:

Contact: Maine Standards Company

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Mary Beltrante

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