Ahlstrom, a global leader in fiber-based specialty materials, is proud to announce that its biological sample collection cards have been officially listed as FDA Class 1 medical devices. This classification by the US Food and Drug Administration (FDA) affirms the safety, reliability, and compliance of GenSaver™ 2.0, GenSaver™ Color 2.0., AutoCollect™, 5 circles, BioSample, HemaSep™ Strip, HemaSep™ Punch and Lipid Saver™ sample collection cards with the highest industry standards.
These products are designed for the secure and efficient collection, transportation, and ambient-temperature storage of biological samples. They provide researchers, healthcare professionals, and forensic experts with a high-quality solution for sample integrity and analysis, and overall address the global trend for quality, personalized healthcare.
The FDA Class 1 listing is particularly important for biological sample collection cards as it ensures the products meet essential regulatory requirements for safety and effectiveness. This designation confirms that the cards are manufactured under stringent quality control processes. The FDA Class 1 listing further solidifies Ahlstrom's commitment to delivering regulatory-compliant, high-performance products to the medical and scientific communities worldwide. The listing facilitates broader adoption by institutions requiring FDA-listed devices for compliance with industry standards and enhances global market access.
"We are pleased to have achieved the FDA Class 1 listing for our biological sample collection cards," said Tamara Quatrano, Vice President, Lab & Life Science business at Ahlstrom. "This milestone underscores our dedication to providing cutting-edge solutions that meet rigorous safety and quality standards while addressing the global trend of quality, personalized healthcare with our technology. Our customers can confidently use our products knowing they comply with FDA regulations."
Ahlstrom's collection cards are ideal for use in critical applications, including diagnostic testing, genetic research, forensic analysis, epidemiological studies, and biobanking. With this FDA listing, Ahlstrom is poised to expand its reach and provide even greater value to industries that rely on accurate and secure sample collection.
