§640.50. Cryoprecipitated AHF.
21 C.F.R. § 640.50
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.
Source. The source material for Cryoprecipitated AHF shall be plasma which may be obtained by whole blood collection or by plasmapheresis.
Notes, amendments, and revision history
Amendments
[42 FR 21774, Apr. 29, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 50 FR 4139, Jan. 29, 1985]
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264.
Source
Source: 38 FR 32089, Nov. 20, 1973, unless otherwise noted.
Amendments
[42 FR 21774, Apr. 29, 1977; 48 FR 13026, Mar. 29, 1983, as amended at 50 FR 4139, Jan. 29, 1985]