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Title 21 → Chapter I → Subchapter F → Part 660 → Subpart F → §660.54 |
Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart F—Anti-Human Globulin
§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.
[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]