[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: 21CFR866.3020]

[Page 240]
 
                        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. 866.3020  Adenovirus serological reagents.

    (a) Identification. Adenovirus serological reagents are devices that 
consist of antigens and antisera used in serological tests to identify 
antibodies to adenovirus in serum. Additionally, some of these reagents 
consist of adenovirus antisera conjugated with a fluorescent dye and are 
used to identify adenoviruses directly from clinical specimens. The 
identification aids in the diagnosis of disease caused by adenoviruses 
and provides epidemiological information on these diseases. Adenovirus 
infections may cause pharyngitis (inflammation of the throat), acute 
respiratory diseases, and certain external diseases of the eye (e.g., 
conjunctivitis).
    (b) Classification. Class I. These devices are 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 25046, June 12, 1989]