[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: 21CFR864.1850]

[Page 232]
 
                        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 B_Biological Stains
 
Sec. 864.1850  Dye and chemical solution stains.


    (a) Identification. Dye and chemical solution stains for medical 
purposes are mixtures of synthetic or natural dyes or nondye chemicals 
in solutions used in staining cells and tissues for diagnostic 
histopathology, cytopathology, or hematology.
    (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. These 
devices are also 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 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]