[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: 21CFR884.1550]

[Page 421]
 
                        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 (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 884.9.

[61 FR 1123, Jan. 16, 1996, as amended at 66 FR 33808, July 25, 2001]

[[Page 422]]