21 C.F.R. § 864.9400 Stabilized enzyme solution.
Title 21 - Food and Drugs
(a) Identification. A stabilized enzyme solution is a reagent intended for medical purposes that is used to enhance the reactivity of red blood cells with certain antibodies, including antibodies that are not detectable by other techniques. These enzyme solutions include papain, bromelin, ficin, and trypsin. (b) Classification. Class II (performance standards). [45 FR 60647, Sept. 12, 1980]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9400 Stabilized enzyme solution.
