[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.2800]

[Page 215]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
               Subpart C--Cell And Tissue Culture Products
 
Sec. 864.2800  Animal and human sera.

    (a) Identification. Animal and human sera are biological products, 
obtained from the blood of humans or other animals, that provide the 
necessary growth-promoting nutrients in a cell culture system.
    (b) Classification. Class I. The devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]