Ahlstrom and ID Biological Systems to manufacture and distribute specimen collection device
Ahlstrom, a leader in high performance fiber-based materials, today announced that it has signed an exclusive agreement with ID Biological Systems to produce specimen collection devices based on Ahlstrom material following regulatory approval in the US.
Following an overwhelming request from the marketplace, Ahlstrom initiated a project to develop a product to meet the strict standards for Newborn Screening programs in the US. As a result of this project, Ahlstrom has received 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) to market Grade 226 as a Class II Medical Device for in-vitro diagnostics.
This grade is manufactured to the CLSI (Clinical & Laboratory Standards Institute) standard for Blood Collection on Filter Paper for Newborn Screening programs (LA4-A4, Vol. 23, Vol. 21) and has been successfully tested to this standard by the Centre for Disease Control’s Newborn Screening Quality program and other third party testing facilities.
The material can be used as a specimen collection media, to collect and transport blood specimen spots, which are later analyzed by a laboratory. The paper is provided as a printed form along with tear-apart forms for collection of patient demographic information.
ID Biological Systems, located in Greenville, SC, USA, will produce the final printed cards using Ahlstrom grade 226. The company, founded by Brad Davin, brings many years of experience in this specific market arena and will be responsible for the printing, sales and marketing of the product and can design cards in single and multiple layer configuration.
To order or discuss your future neonatal collection devices purchases, please contact:
ID Biological Systems – Brad Davin, Phone: +1-864-299-8787, Fax: +1-864-299-8789,
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