[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: 21CFR866.2050]

[Page 256]
 
                        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. 866.2050  Staphylococcal typing bacteriophage.


    (a) Identification. A staphylococcal typing bacteriophage is a 
device consisting of a bacterial virus intended for medical purposes to 
identify pathogenic staphylococcal bacteria through use of the 
bacteria's susceptibility to destruction by the virus. Test results are 
used principally for the collection of epidemiological information.
    (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 25045, June 12, 1989; 66 
FR 38790, July 25, 2001]