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Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES--
PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
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 | 660.1 | Antibody to Hepatitis B Surface Antigen. |
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| 660.2 | General requirements. |
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| 660.3 | Reference panel. |
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| 660.4 | Potency test. |
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| 660.5 | Specificity. |
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| 660.6 | Samples; protocols; official release. |
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| 660.20 | Blood Grouping Reagent. |
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| 660.21 | Processing. |
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| 660.22 | Potency requirements with reference preparations. |
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| 660.25 | Potency tests without reference preparations. |
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| 660.26 | Specificity tests and avidity tests. |
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| 660.28 | Labeling. |
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| 660.30 | Reagent Red Blood Cells. |
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| 660.31 | Suitability of the donor. |
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| 660.32 | Collection of source material. |
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| 660.33 | Testing of source material. |
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| 660.34 | Processing. |
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| 660.35 | Labeling. |
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| 660.36 | Samples and protocols. |
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| 660.40 | Hepatitis B Surface Antigen. |
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| 660.41 | Processing. |
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| 660.42 | Reference panel. |
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| 660.43 | Potency test. |
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| 660.44 | Specificity. |
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| 660.45 | Labeling. |
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| 660.46 | Samples; protocols; official release. |
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| 660.50 | Anti-Human Globulin. |
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| 660.51 | Processing. |
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| 660.52 | Reference preparations. |
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| 660.53 | Controls for serological procedures. |
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| 660.54 | Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties. |
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| 660.55 | Labeling. |
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