[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: 21CFR864.7040]

[Page 231]
 
                        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 H--Hematology Kits and Packages
 
Sec. 864.7040  Adenosine triphosphate release assay.


    (a) Identification. An adenosine triphosphate release assay is a 
device that measures the release of adenosine triphosphate (ATP) from 
platelets following aggregation. This measurement is made on platelet-
rich plasma using a photometer and a luminescent firefly extract. 
Simultaneous measurements of platelet aggregation and ATP release are 
used to evaluate platelet function disorders.
    (b) Classification. Class I (general controls).

[45 FR 60609, Sept. 12, 1980]