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

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

(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]