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5 years ago

MyCells® - Platelet Rich Plasma harvesting kit : from ... - My-cells.net

MyCells® - Platelet Rich Plasma harvesting kit : from ... - My-cells.net

MyCells® harvesting kit Current Regulatory Status �All Kaylight PRP harvesting kits components have been approved by the following regulatory bodies: �ISO 13485 (Nov 07). �CE Class IIA 1023 for in vivo usage for reinjection (Feb 08). �FDA 21-CFR-880.5860 (Sep 09). 55

Kaylight Technologies: Producer: � Vacuum PRP harvesting Tubes and all kit components (except CaCl 2 ) will be produced by Kaylight Technologies Ltd, Holon, Israel. Previous Experience with PRP � In the dentistry field Certificates: Kaylight Technologies Ltd, Holon, Israel holds the following quality certificates: � ISO-9001/9002 � ISO 13485 � GMP Certificate � Free Sell Certificate � CE – In Vitro Diagnosis � CE – Medical Devices for kit accessories � CE 1023 – In vivo usage for re-injection in humans � FDA 21-CFR-880.5860 for marketing in the USA Remarks: � All syringes in the kit are sterile, pyrogen and latex free. � All tubes and filters undergo gamma irradiation. � Each batch of tubes specifically undergo tests for sterility and pyrogenicity. 56

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