Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. Additional Standards for Diagnostic Substances for Laboratory Tests
  7. Anti-Human Globulin
  8. Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.

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§ 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]


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