Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter F - BIOLOGICSPart 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart F - ANTI-HUMAN GLOBULIN
Section 660.54 - Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties

21 C.F.R. § 660.54

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Current through October 31, 2024
Section 660.54 - Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties

The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research:

(a) Potency tests for determining anti-IgG and anti-complement activity.
(b) Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.

21 C.F.R. §660.54

50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11014, Mar. 26, 1990; 67 FR 9587 , Mar. 4, 2002; 70 FR 14986 , Mar. 24, 2005