21 CFR 884.1550
§ 884.1550 Amniotic fluid sampler (amniocentesis tray).
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 884.1550, § 884.1550 Amniotic fluid sampler (amniocentesis tray), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90785
- Permanent ID
ys:prov:90785@1- SHA-256
e72a8d45a814de6fa4b056b606b531617df5fe4cbd6e36cca70009b27c594e1f
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.