About
Company News
Maine Standards Company, LLC Releases New VALIDATE®
Cardiac Marker Test Set
(Windham, ME)--Maine Standards Company, LLC recently received clearance from the U.S. Food and Drug Administration (FDA) for the VALIDATE® CM2 test set. The VALIDATE® CM2 test set includes BNP / nt-proBNP, hsCRP and Troponin for easier calibration verification / linearity testing. This clearance will allow clinical laboratories to more easily complete their required cardiac marker linearity testing and to maximize reportable ranges while minimizing manual dilutions.
VALIDATE® test sets make linearity testing easier. Each test kit contains five levels prepared using the CLSI recommended "equal delta" method for linearity testing. The test kits are pre-diluted and ready to use as is. A technician simply adds product from the dropper bottle directly into the sample cup and runs as a patient sample, but in triplicate or duplicate. Using VALIDATE® is that easy.
VALIDATE® CM2 test sets will be available in two product configurations. Multiple product configurations are offered to meet the different needs of the many instrument systems available for the laboratory. These configurations are formulated to validate and maximize reportable ranges while minimizing manual dilutions.
Maine Standards Company’s MSDRx® data reduction software is available at no charge for real time data analysis. A laboratory can perform the data reduction or send their data to Maine Standards, where technical specialists in Maine will complete the data reduction quickly. Turnaround of data reduction from Maine Standards is typically less than one week. Data analysis (data reduction) services are included with the purchase of all VALIDATE® products.
Maine Standards Company, LLC manufactures VALIDATE® test sets for over 80 analytes, including General Chemistries, Urine Chemistries, Electrolytes, Enzymes, Lipids, TDMs, Cardiac Markers, Thyroids and Serum Proteins. The company is committed to helping clinical laboratories with their linearity needs. Personnel at Maine Standards Company have many years of experience in the linearity market and are dedicated to providing the highest quality materials and the best customer support 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, LLC is registered to ISO 13485:2003.
Maine Standards Company, LLC
765 Roosevelt TrailWindham, ME 04062-5365
Toll-free: 800-377-9684
or 207-892-1300
Fax: 207-892-2266
Hours:
8:30 AM to 5:00 PM,
Eastern Time, Monday
through Thursday.
8:30 AM to 4:00 PM on Friday.
© 2001-2010 Maine Standards Company, LLC. VALIDATE is a registered trademark of Maine Standards Company, LLC.