[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: 21CFR866.3035]

[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. 866.3035  Arizona spp. serological reagents.

    (a) Identification. Arizona spp. serological reagents are devices 
that consist of antisera and antigens used to identify Arizona spp. in 
cultured isolates derived from clinical specimens. The identification 
aids in the diagnosis of disease caused by bacteria belonging to the 
genus Arizona and provides epidemiological information on diseases 
caused by these microorganisms. Arizona spp. can cause gastroenteritis 
(food poisoning) and sepsis (blood poisoning).
    (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]