CUMBERLAND FORESIDE, Maine--(BUSINESS WIRE)--Maine Standards Company, LLC announced that it has received 510(k) clearance for its VALIDATE® PSA calibration verification / linearity test kit. The VALIDATE® PSA contains total and free PSA in a human serum- base matrix. Clearance of this product will allow clinical laboratories to complete their required PSA calibration verification / linearity testing and maximize the reportable range while minimizing manual dilutions.
The new calibration verification / linearity kit will provide laboratories confidence in their testing results. The addition of PSA to the Maine Standards Company portfolio of products demonstrates the company’s continued commitment to manufacturer calibration verification / linearity products to meet customer’s needs.
VALIDATE® PSA is designed for use on all major manufacturers’ clinical laboratory instruments. Each test 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.
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, LLC
Maine Standards Company is located in Cumberland Foreside, Maine. Maine Standards Company manufactures VALIDATE® test kits for analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins and Vitamin D. The company is committed to helping clinical laboratories with their calibration verification / linearity needs. 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: www.mainestandards.com