[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: 21CFR864.2260]

[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. 864.2260  Chromosome culture kit.

    (a) Identification. A chromosome culture kit is a device containing 
the necessary ingredients (e.g., Minimum Essential Media (MEM) of 
McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, 
antibiotics, and heparin) used to culture tissues for diagnosis of 
congenital chromosome abnormalities.
    (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 the limitations in Sec. 864.9.

[45 FR 60585, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]