[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.2360]

[Page 216]
 
                        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 (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.

[45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]

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