Title 21

PART 660

Part 660 - Additional Standards For Diagnostic Substances For Laboratory Tests

PART 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS 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. Cross References:

For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.

21:7.0.1.1.8.1SUBPART A
Subpart A - Antibody to Hepatitis B Surface Antigen
21:7.0.1.1.8.1.1.1SECTION 660.1
   660.1 Antibody to Hepatitis B Surface Antigen.
21:7.0.1.1.8.1.1.2SECTION 660.2
   660.2 General requirements.
21:7.0.1.1.8.1.1.3SECTION 660.3
   660.3 Reference panel.
21:7.0.1.1.8.1.1.4SECTION 660.4
   660.4 Potency test.
21:7.0.1.1.8.1.1.5SECTION 660.5
   660.5 Specificity.
21:7.0.1.1.8.1.1.6SECTION 660.6
   660.6 Samples; protocols; official release.
21:7.0.1.1.8.2SUBPART B
Subpart B [Reserved]
21:7.0.1.1.8.3SUBPART C
Subpart C - Blood Grouping Reagent
21:7.0.1.1.8.3.1.1SECTION 660.20
   660.20 Blood Grouping Reagent.
21:7.0.1.1.8.3.1.2SECTION 660.21
   660.21 Processing.
21:7.0.1.1.8.3.1.3SECTION 660.22
   660.22 Potency requirements with reference preparations.
21:7.0.1.1.8.3.1.4SECTION 660.25
   660.25 Potency tests without reference preparations.
21:7.0.1.1.8.3.1.5SECTION 660.26
   660.26 Specificity tests and avidity tests.
21:7.0.1.1.8.3.1.6SECTION 660.28
   660.28 Labeling.
21:7.0.1.1.8.4SUBPART D
Subpart D - Reagent Red Blood Cells
21:7.0.1.1.8.4.1.1SECTION 660.30
   660.30 Reagent Red Blood Cells.
21:7.0.1.1.8.4.1.2SECTION 660.31
   660.31 Eligibility of donor.
21:7.0.1.1.8.4.1.3SECTION 660.32
   660.32 Collection of source material.
21:7.0.1.1.8.4.1.4SECTION 660.33
   660.33 Testing of source material.
21:7.0.1.1.8.4.1.5SECTION 660.34
   660.34 Processing.
21:7.0.1.1.8.4.1.6SECTION 660.35
   660.35 Labeling.
21:7.0.1.1.8.4.1.7SECTION 660.36
   660.36 Samples and protocols.
21:7.0.1.1.8.5SUBPART E
Subpart E - Hepatitis B Surface Antigen
21:7.0.1.1.8.5.1.1SECTION 660.40
   660.40 Hepatitis B Surface Antigen.
21:7.0.1.1.8.5.1.2SECTION 660.41
   660.41 Processing.
21:7.0.1.1.8.5.1.3SECTION 660.43
   660.43 Potency test.
21:7.0.1.1.8.5.1.4SECTION 660.44
   660.44 Specificity.
21:7.0.1.1.8.5.1.5SECTION 660.45
   660.45 Labeling.
21:7.0.1.1.8.5.1.6SECTION 660.46
   660.46 Samples; protocols; official release.
21:7.0.1.1.8.6SUBPART F
Subpart F - Anti-Human Globulin
21:7.0.1.1.8.6.1.1SECTION 660.50
   660.50 Anti-Human Globulin.
21:7.0.1.1.8.6.1.2SECTION 660.51
   660.51 Processing.
21:7.0.1.1.8.6.1.3SECTION 660.52
   660.52 Reference preparations.
21:7.0.1.1.8.6.1.4SECTION 660.53
   660.53 Controls for serological procedures.
21:7.0.1.1.8.6.1.5SECTION 660.54
   660.54 Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.
21:7.0.1.1.8.6.1.6SECTION 660.55
   660.55 Labeling.