§864.9285. Automated cell-washing centrifuge for immuno-hematology.
21 C.F.R. § 864.9285
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Amendments
[45 FR 60646, Sept. 12, 1980]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60646, Sept. 12, 1980]