21 CFR 864.9400 - Stabilized enzyme solution.

§ 864.9400 Stabilized enzyme solution.

(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]

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