A U.S. Standard Antihemophilic Factor (Factor VIII) preparation may be obtained from the Center for Biologics Evaluation and Research, (HFM-407) (see mailing addresses in § 600.2 of this chapter ) for use in the preparation of a working reference to be employed in a quality control potency test of Cryoprecipitated AHF.
21 CFR Part 640 · Additional Standards for Human Blood and Blood Products
§ 640.55 U.S. Standard preparation
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 42 FR 21774 29 Apr 1977
- 49 FR 23834 8 Jun 1984
- 50 FR 4140 29 Jan 1985
- 55 FR 11013 26 Mar 1990
- 70 FR 14985 24 Mar 2005