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21 C.F.R. PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

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

Suitability of the 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.