(a) Proper name and definition. The proper name of this product shall be Cryoprecipitated AHF. The product is defined as a preparation of antihemophilic factor, which is obtained from a single unit of plasma collected and processed in a closed system.
(b) Source. The source material for Cryoprecipitated AHF shall be plasma which may be obtained by whole blood collection or by plasmapheresis. [42 FR 21774, Apr. 29, 1977; 48 FR 13026, Mar. 29, 1983; as amended at 50 FR 4139, Jan. 29, 1985]