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Electronic Code of Federal Regulations

e-CFR data is current as of November 14, 2019

Title 21Chapter ISubchapter FPart 660


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER F—BIOLOGICS

PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

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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.
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Subpart B—[RESERVED]

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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.
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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.
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Subpart E—HEPATITIS B SURFACE ANTIGEN

§660.40
Hepatitis B Surface Antigen.
§660.41
Processing.
§660.43
Potency test.
§660.44
Specificity.
§660.45
Labeling.
§660.46
Samples; protocols; official release.
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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.

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