[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR884.1560]

[Page 422]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES--Table of Contents
 
       Subpart B--Obstetrical and Gynecological Diagnostic Devices
 
Sec. 884.1560  Fetal blood sampler.

    (a) Identification. A fetal blood sampler is a device used to obtain 
fetal blood transcervically through an endoscope by puncturing the fetal 
skin with a short blade and drawing blood into a heparinized tube. The 
fetal blood pH is determined and used in the diagnosis of fetal distress 
and fetal hypoxia.
    (b) Classification. Class II (performance standards).