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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests |
| Subpart A - Antibody to Hepatitis B Surface Antigen |
| § 660.1 - Antibody to Hepatitis B Surface Antigen. |
| § 660.2 - General requirements. |
| § 660.3 - Reference panel. |
| § 660.4 - Potency test. |
| § 660.5 - Specificity. |
| § 660.6 - Samples; protocols; official release. |
| Subpart B - XXX |
| Subpart C - Blood Grouping Reagent |
| § 660.20 - Blood Grouping Reagent. |
| § 660.21 - Processing. |
| § 660.22 - Potency requirements with reference preparations. |
| § 660.25 - Potency tests without reference preparations. |
| § 660.26 - Specificity tests and avidity tests. |
| § 660.28 - Labeling. |
| Subpart D - Reagent Red Blood Cells |
| § 660.30 - Reagent Red Blood Cells. |
| § 660.31 - Eligibility of donor. |
| § 660.32 - Collection of source material. |
| § 660.33 - Testing of source material. |
| § 660.34 - Processing. |
| § 660.35 - Labeling. |
| § 660.36 - Samples and protocols. |
| Subpart E - Hepatitis B Surface Antigen |
| § 660.40 - Hepatitis B Surface Antigen. |
| § 660.41 - Processing. |
| § 660.42 - Reference panel. |
| § 660.43 - Potency test. |
| § 660.44 - Specificity. |
| § 660.45 - Labeling. |
| § 660.46 - Samples; protocols; official release. |
| Subpart F - Anti-Human Globulin |
| § 660.50 - Anti-Human Globulin. |
| § 660.51 - Processing. |
| § 660.52 - Reference preparations. |
| § 660.53 - Controls for serological procedures. |
| § 660.54 - Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. |
| § 660.55 - Labeling. |