21 C.F.R. § 884.1550 Amniotic fluid sampler (amniocentesis tray).
Title 21 - Food and Drugs
(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 §884.9. [61 FR 1123, Jan. 16, 1996, as amended at 66 FR 33808, July 25, 2001]
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices
§ 884.1550 Amniotic fluid sampler (amniocentesis tray).
