(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 (special controls). The 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 60647, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]