[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: 21CFR864.2360]

[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. 864.2360  Mycoplasma detection media and components.

    (a) Identification. Mycoplasma detection media and components are 
used to detect and isolate mycoplasma pleuropneumonia-like organisms 
(PPLO), a common microbial contaminant in cell cultures.
    (b) Classification. Class I. These 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]