[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR866.2050]

[Page 235-236]
 
                        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.

[[Page 236]]

    (b) Classification. Class I. The 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 54 FR 25045, June 12, 1989]