§ 862.1675. Blood specimen collection device.
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/us/cfr/t21/s§ 862.1675·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
(b)Classification. Class II.