Title 21 Part 884 → Subpart B → §884.1550

Title 21 → Chapter I → Subchapter H → Part 884 → Subpart B → §884.1550

Electronic Code of Federal Regulations e-CFR

Title 21 Part 884 → Subpart B → §884.1550

e-CFR data is current as of February 20, 2020

Title 21Chapter ISubchapter HPart 884Subpart B → §884.1550

Title 21: Food and Drugs
Subpart B—Obstetrical and Gynecological Diagnostic Devices

§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 §884.9.

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