21 CFR § 862.1675 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1675 Blood specimen collection device.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(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.

← § 862.1670 Sorbitol dehydrogenase test system.§ 862.1676 Blood collection device for cell-free nucleic acids. →