Profile: Biosafe Sa develops, manufactures and supplies solutions for cell processing in both stem cell banking and regenerative medicine. We specialize in adult stem cell therapy. Our PBSC protocol is designed for the volume reduction of peripheral blood stem cell preparations following leukaphaeresis. Our PBSC-Washing protocol is designed for the automated washing of thawed leukaphaeresis products. Our GVR protocol is conceived for volume reduction of different blood products and specially adapted for bone marrow.
FDA Registration Number: 3004728017
US Agent: N/a / N/a
4 Products/Services (Click for related suppliers)
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• Blood Mixing and Weighing Device (FDA Code: KSQ / 864.9195) A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected. |
• Blood Transfer Unit (FDA Code: KSB / 864.9875) A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another. |
• Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT / 880.5965) A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design. |
• Refrigerated Centrifuges (FDA Code: JQC / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use. |