|
Section 660.1
|
General requirements |
|
Section 660.2
|
Reference panel |
|
Section 660.3
|
Potency test |
|
Section 660.4
|
Specificity |
|
Section 660.5
|
Samples; protocols; official release |
|
Section 660.6
|
Blood Grouping Reagent |
|
Section 660.20
|
Processing |
|
Section 660.21
|
Potency requirements with reference preparations |
|
Section 660.22
|
Potency tests without reference preparations |
|
Section 660.25
|
Specificity tests and avidity tests |
|
Section 660.26
|
Labeling |
|
Section 660.28
|
Reagent Red Blood Cells |
|
Section 660.30
|
Suitability of the donor |
|
Section 660.31
|
Collection of source material |
|
Section 660.32
|
Testing of source material |
|
Section 660.33
|
Processing |
|
Section 660.34
|
Labeling |
|
Section 660.35
|
Samples and protocols |
|
Section 660.36
|
Hepatitis B Surface Antigen |
|
Section 660.40
|
Processing |
|
Section 660.41
|
Potency test |
|
Section 660.43
|
Specificity |
|
Section 660.44
|
Labeling |
|
Section 660.45
|
Samples; protocols; official release |
|
Section 660.46
|
Anti-Human Globulin |
|
Section 660.50
|
Processing |
|
Section 660.51
|
Reference preparations |
|
Section 660.52
|
Controls for serological procedures |
|
Section 660.53
|
Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties |
|
Section 660.54
|
Labeling |
|
Section 660.55
|
Allergenic Products |