[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR660.30]

[Page 124-125]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 660_ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS--
 
                    Subpart D_Reagent Red Blood Cells
 
Sec. 660.30  Reagent Red Blood Cells.

    Source: 52 FR 37450, Oct. 7, 1987, unless otherwise noted.


    (a) Proper name and definition. The proper name of the product shall 
be Reagent Red Blood Cells, which shall consist of a preparation of 
human red blood cells used to detect or identify human blood-group 
antibodies.
    (b) Source. Reagent Red Blood Cells shall be prepared from human 
peripheral blood meeting the criteria of Sec. Sec. 660.31 and 660.32 of 
this chapter, or from umbilical cord cells which shall be collected and 
prepared according to

[[Page 125]]

the manufacturer's biologics license application.

[52 FR 37450, Oct. 7, 1987, as amended at 64 FR 56454, Oct. 20, 1999]