21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices
(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.
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Federal Register documents that created or amended this section.