[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: 21CFR866.3010]

[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. 866.3010  Acinetobacter calcoaceticus serological reagents.


    (a) Identification. Acinetobacter calcoaceticus serological reagents 
are devices that consist of Acinetobacter calcoaceticus antigens and 
antisera used to identify this bacterium from cultured isolates derived 
from clinical specimens. The identification aids in the diagnosis of 
disease caused by the bacterium Acinetobacter calcoaceticus and provides 
epidemiological information on disease caused by this microorganism. 
This organism becomes pathogenic in patients with burns or with 
immunologic deficiency, and infection can result in 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]