[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.5425]

[Page 228]
 
                        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. 864.5425  Multipurpose system for in vitro coagulation studies.

    (a) Identification. A multipurpose system for in vitro coagulation 
studies is a device consisting of one automated or semiautomated 
instrument and its associated reagents and controls. The system is used 
to perform a series of coagulation studies and coagulation factor 
assays.
    (b) Classification. Class II (performance standards).

[45 FR 60599, Sept. 12, 1980]