---
kind: "section"
citation: "21 C.F.R. § 884.1560"
title: "21"
number: "884.1560"
heading: "Fetal blood sampler."
url: "https://uscodex.org/cfr/21/884.1560"
---

# §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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.