Section 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 .45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790 , July 25, 2001