[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: 21CFR866.3220]

[Page 244]
 
                        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 D--Serological Reagents
 
Sec. 866.3220  Entamoeba histolytica serological reagents.

    (a) Identification. Entamoeba histolytica serological reagents are 
devices that consist of antigens and antisera used in serological tests 
to identify antibodies to Entamoeba histolytica in serum. Additionally, 
some of these reagents consist of antisera conjugated with a fluorescent 
dye (immunofluorescent reagents) used to identify Entamoeba histolytica 
directly from clinical specimens. The identification aids in the 
diagnosis of amebiasis caused by the microscopic protozoan parasite 
Entamoeba histolytica and provides epidemiological information on 
diseases caused by this parasite. The parasite may invade the skin, 
liver, intestines, lungs, and diaphragm, causing disease conditions such 
as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary 
lesions.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec. 866.9.

[47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, 1982, as amended at 63 
FR 59226, Nov. 3, 1998]