[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.2280]

[Page 233]
 
                        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. 864.2280  Cultured animal and human cells.

    (a) Identification. Cultured animal and human cells are in vitro 
cultivated cell lines from the tissue of humans or other animals which 
are used in various diagnostic procedures, particularly diagnostic 
virology and cytogenetic studies.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to Sec. 864.9.

[45 FR 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]