CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F - BIOLOGICS

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 [Reserved]

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.
   § 660.43 - 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.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.