[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: 21CFR866.2560]

[Page 259]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866_IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart C_Microbiology Devices
 
Sec. 866.2560  Microbial growth monitor.

    (a) Identification. A microbial growth monitor is a device intended 
for medical purposes that measures the concentration of bacteria 
suspended in a liquid medium by measuring changes in light scattering 
properties, optical density, electrical impedance, or by making direct 
bacterial counts. The device aids in the diagnosis of disease caused by 
pathogenic microorganisms.
    (b) Classification. Class I. With the exception of automated blood 
culturing system devices that are used in testing for bacteria, fungi, 
and other microorganisms in blood and other normally sterile body 
fluids, this device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 60 FR 38482, July 27, 1995]