Human allotypic marker immunological test system.

(a) Identification. A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA 2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000]