21 CFR §640.50
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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.