Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart I - Hematology Reagents / § 864.8500 Lymphocyte separation medium.
§ 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.