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[A1]

Electronic Code of Federal Regulations

e-CFR data is current as of July 1, 2020

Title 21 → Chapter I → Subchapter F → Part 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

rule

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.
rule

Subpart B—[RESERVED]

rule

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.
rule

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.
rule

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.
rule

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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