[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: 21CFR864.5700]

[Page 220]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
       Subpart F--Automated and Semi-Automated Hematology Devices
 
Sec. 864.5700  Automated platelet aggregation system.

    (a) Identification. An automated platelet aggregation system is a 
device used to determine changes in platelet shape and platelet 
aggregation following the addition of an aggregating reagent to a 
platelet-rich plasma.
    (b) Classification. Class II (performance standards).

[45 FR 60602, Sept. 12, 1980]