AUSTIN, February 2019: OriGen Biomedical, Inc., a global medical device manufacturer focused on the production of cryopreservation, cell culture, and ECMO respiratory products, is pleased to announce that the United States Food and Drug Administration (FDA) has cleared the CryoStore™ Multi-Chamber Freezing Bag through the 510(k) process for the indication of freezing blood components.
OriGen Biomedical’s CryoStore™ Bags are the industry-preferred cryogenic freezing bags. The CryoStore™ Multi-Chamber Freezing Bag is OriGen’s solution to smaller volume cryopreservation challenges. As the cell therapy industry continues to grow, adapt, and improve, OriGen strives to provide the most relevant products that meet the high-quality standards that OriGen’s customers have come to expect.
The CryoStore™ Multi-Chamber Freezing Bags are transforming future possibilities. Consider the scalable storage of your cellular products, samples or cryovials in cassettes. The CryoStore™ Multi-Chamber Freezing Bag has four to five 4-6ml chambers that allow for multiple post-thaw applications. The CryoStore™ Multi-Chamber Freezing Bag is made from the same rugged EVA as our CryoStore™ Freezing Bags and the proof of durability is in the performance testing and validations conducted by OriGen and exemplified through our customer’s success stories. The CryoStore™ Multi-Chamber Freezing Bag has necessary traceability with matching bag and tube printing for each chamber.
“We believe that this product design which has now received FDA marketing clearance will be a significant step forward in the advance of regenerative medicine and immunotherapy,” said Richard Martin, CEO and President of OriGen Biomedical, Inc. “With increasing requirements for product traceability in emerging therapies, this product will help our customers in meeting that regulatory oversight.”
The OriGen Biomedical CryoStore™ Multi-Chamber Freezing Bag is available for sale in the EU, Canada, and the USA. For more information on the CryoStore Flex Bag, please visit the product page.
OriGen Biomedical’s CryoStore™ Bags are the industry-preferred cryogenic freezing bags. The CryoStore™ Multi-Chamber Freezing Bag is OriGen’s solution to smaller volume cryopreservation challenges. As the cell therapy industry continues to grow, adapt, and improve, OriGen strives to provide the most relevant products that meet the high-quality standards that OriGen’s customers have come to expect.
The CryoStore™ Multi-Chamber Freezing Bags are transforming future possibilities. Consider the scalable storage of your cellular products, samples or cryovials in cassettes. The CryoStore™ Multi-Chamber Freezing Bag has four to five 4-6ml chambers that allow for multiple post-thaw applications. The CryoStore™ Multi-Chamber Freezing Bag is made from the same rugged EVA as our CryoStore™ Freezing Bags and the proof of durability is in the performance testing and validations conducted by OriGen and exemplified through our customer’s success stories. The CryoStore™ Multi-Chamber Freezing Bag has necessary traceability with matching bag and tube printing for each chamber.
“We believe that this product design which has now received FDA marketing clearance will be a significant step forward in the advance of regenerative medicine and immunotherapy,” said Richard Martin, CEO and President of OriGen Biomedical, Inc. “With increasing requirements for product traceability in emerging therapies, this product will help our customers in meeting that regulatory oversight.”
The OriGen Biomedical CryoStore™ Multi-Chamber Freezing Bag is available for sale in the EU, Canada, and the USA. For more information on the CryoStore Flex Bag, please visit the product page.
