21 CFR § 884.1560 - Fetal blood sampler.

---
identifier: "/us/cfr/t21/s884.1560"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.1560 - Fetal blood sampler."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.1560"
section_name: "Fetal blood sampler."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 884.1560 Fetal blood sampler.

(a) *Identification.* A fetal blood sampler is a device used to obtain fetal blood transcervically through an endoscope by puncturing the fetal skin with a short blade and drawing blood into a heparinized tube. The fetal blood pH is determined and used in the diagnosis of fetal distress and fetal hypoxia.

(b) *Classification.* Class II (performance standards).