[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: 21CFR866.2160]

[Page 236]
 
                        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 C--Microbiology Devices
 
Sec. 866.2160  Coagulase plasma.

    (a) Identification. Coagulase plasma is a device that consists of 
freeze-dried animal or human plasma that is intended for medical 
purposes to perform coagulase tests primarily on staphylococcal 
bacteria. When reconstituted, the fluid plasma is clotted by the action 
of the enzyme coagulase which is produced by pathogenic staphylococci. 
Test results are used primarily as an aid in the diagnosis of disease 
caused by pathogenic bacteria belonging to the genus Staphylococcus and 
provide epidemiological information on disease caused by these 
microorganisms.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[47 FR 50823, Nov. 9, 1982, as amended at 61 FR 1119, Jan. 16, 1996]