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2018 10 23ensp;0183;ensp;NOTE The revision of this Import Alert dated 09/28/2017, Updates the Guidance section. Changes are bracketed by asterisks (***). Note Foreign firms previously subject to detention without physical examination under Import Alert 73 03 are now listed on this alert. FDA believes these devices are Class 3 and need a PMA.
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2018 10 21ensp;0183;ensp;Flow cytometry cell sorters have a collection system unlike flow cytometry analyzers. The collection process starts when a sample is injected into a stream of sheath fluid that passes through the flow cell and laser intercepts. The stream then carries the cell through a vibrating nozzle.
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