[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: 21CFR866.2350]

[Page 257]
 
                        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. 866.2350  Microbiological assay culture medium.

    (a) Identification. A microbiological assay culture medium is a 
device that consists primarily of liquid or solid biological materials 
intended for medical purposes to cultivate selected test microorganisms 
in order to measure by microbiological procedures the concentration in a 
patient's serum of certain substances, such as amino acids, 
antimicrobial agents, and vitamins. The concentration of these 
substances is measured by their ability to promote or inhibit the growth 
of the test organism in the innoculated medium. Test results aid in the 
diagnosis of disease resulting from either deficient or excessive 
amounts of these substances in a patient's serum. Tests results may also 
be used to monitor the effects of the administration of certain 
antimicrobial drugs.
    (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. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 
FR 38791, July 25, 2001]