[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.3600]

[Page 218]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
          Subpart D--Pathology Instrumentation and Accessories
 
Sec. 864.3600  Microscopes and accessories.

    (a) Identification. Microscopes and accessories are optical 
instruments used to enlarge images of specimens, preparations, and 
cultures for medical purposes. Variations of microscopes and accessories 
(through a change in the light source) used for medical purposes include 
the following:
    (1) Phase contrast microscopes, which permit visualization of 
unstained preparations by altering the phase relationship of light that 
passes around the object and through the object.
    (2) Fluorescense microscopes, which permit examination of specimens 
stained with fluorochromes that fluoresce under ultraviolet light.
    (3) Inverted stage microscopes, which permit examination of tissue 
cultures or other biological specimens contained in bottles or tubes 
with the light source mounted above the specimen.
    (b) Classification. Class I (general controls). These devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 864.9. If the 
device is not labeled or otherwise represented as sterile, it is exempt 
from the current 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.

[45 FR 60590, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]