[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: 21CFR866.2600]

[Page 249]
 
                        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. 866.2600  Wood's fluorescent lamp.

    (a) Identification. A Wood's fluorescent lamp is a device intended 
for medical purposes to detect fluorescent materials (e.g., fluorescein 
pigment produced by certain microorganisms) as an aid in the 
identification of these 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 the limitations in Sec. 866.9. The device is 
also exempt from the good manufacturing practice regulations in part 820 
of this chapter, with the exception of Sec. 820.180, with respect to 
general requirements concerning records, and Sec. 820.198, with respect 
to complaint files.

[47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]