[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.2240]

[Page 223]
 
                        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. 864.2240  Cell and tissue culture supplies and equipment.

    (a) Identification. Cell and tissue culture supplies and equipment 
are devices that are used to examine, propagate, nourish, or grow cells 
and tissue cultures. These include such articles as slide culture 
chambers, perfusion and roller apparatus, cell culture suspension 
systems, and tissue culture flasks, disks, tubes, and roller bottles.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. If the 
devices are not labeled or otherwise represented as sterile, they are 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.

[45 FR 60584, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]