[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: 21CFR884.1550]

[Page 414]
 
                        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. 884.1550  Amniotic fluid sampler (amniocentesis tray).

    (a) Identification. The amniotic fluid sampler (amniocentesis tray) 
is a collection of devices used to aspirate amniotic fluid from the 
amniotic sac via a transabdominal approach. Components of the 
amniocentesis tray include a disposable 3 inch 20 gauge needle with 
stylet and a 30 cc. syringe, as well as the various sample collection 
accessories, such as vials, specimen containers, medium, drapes, etc. 
The device is used at 16-18 weeks gestation for antepartum diagnosis of 
certain congenital abnormalities or anytime after 24 weeks gestation 
when used to assess fetal maturity.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[61 FR 1123, Jan. 16, 1996]