View all text of Subpart I [§ 864.8100 - § 864.8950]
§ 864.8500 - Lymphocyte separation medium.
(a) Identification. A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.
(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.