21 CFR § 864.9285 Hematology and Pathology Devices

§ 864.9285 Automated cell-washing centrifuge for immuno-hematology.

Current through Sep 8, 2026 · Read all of Part 864

(a) Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.

(b) Classification. Class II (performance standards).

[45 FR 60646, Sept. 12, 1980]

← § 864.9275 Blood bank centrifuge for in vitro diagnostic use.§ 864.9300 Automated Coombs test systems. →