[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2660]

[Page 249-250]
 
                        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. 866.2660  Microorganism differentiation and identification device.

    (a) Identification. A microorganism differentiation and 
identification device is a device intended for medical purposes that 
consists of one or more components, such as differential culture media, 
biochemical reagents, and

[[Page 250]]

paper discs or paper strips impregnated with test reagents, that are 
usually contained in individual compartments and used to differentiate 
and identify selected microorganisms. The device aids in the diagnosis 
of disease.
    (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 Sec. 866.9.

[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2311, Jan. 14, 2000]