CFR section
21 CFR 660.52: Reference preparations
PART 660-ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS · Subpart F-Anti-Human Globulin
Key facts
| Citation | 21 CFR 660.52 |
|---|---|
| Section | Reference preparations |
| Part | PART 660-ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS |
| Subpart | Subpart F-Anti-Human Globulin |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | Reference Anti-Human Globulin preparations shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002, and shall be used as described in the accompanying package insert for determining the potency of Anti-Human Globulin. |
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