[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: 21CFR864.6550]

[Page 230]
 
                        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 G--Manual Hematology Devices
 
Sec. 864.6550  Occult blood test.

    (a) Identification. An occult blood test is a device used to detect 
occult blood in urine or feces. (Occult blood is blood present in such 
small quantities that it can be detected only by chemical tests of 
suspected material, or by microscopic or spectroscopic examination.)
    (b) Classification. Class II (performance standards).

[45 FR 60606, Sept. 12, 1980]