Miltenyi Biotec Receives 510K Clearance From FDA to Market CryoMACS Freezing Bags

Auburn, CA (PRWEB) January 31, 2010

Bergisch Gladbach, Germany. Miltenyi Biotec has received 510(k) clearance from the Food and Drug Administration's Center for Biologics Evaluation (CBER) for their line of CryoMACS® Freezing Bags. The CryoMACS Freezing Bags are intended for a single cycle of freezing, storage (down to –196 °C), and subsequent thawing (at 37 °C) of hematopoietic progenitor cells.

The CryoMACS Freezing Bags are available in five sizes: 50 mL, 250 mL, 500 mL, 750 mL and 1000 mL. An added feature of the CryoMACS Freezing Bag product is that each bag comes individually wrapped in a sterile packaging, and includes an overwrap bag for customers who desire secondary containment of cellular suspensions.

"This is an important regulatory clearance in that it affords the market an alternative to currently available bags, which do not have the added benefits of sterile packaging, or the added protection afforded by the overwrap container," said Stefan Miltenyi, President of Miltenyi Biotec. "These advances will prove valuable to the US cellular therapy market, which consistently strives to provide the highest quality of cellular products to their patients." The CryoMACS Freezing Bags have been marketed by Miltenyi Biotec throughout Europe, Australia and Asia for about one year.

About Miltenyi Biotec
Miltenyi Biotec, founded in 1989, is a privately held company with corporate headquarters located in Bergisch Gladbach, Germany. The company develops, manufactures, and sells more than one thousand products and services; designed to advance the fields of cell biology, immunology, regenerative medicine, and molecular biology. The Company offers a complete portfolio of products that enable scientific discovery and research from the early research through late stage clinical therapies.

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