21 C.F.R. § 884.1560

Fetal blood sampler.

Last amended: 2016Year: 2026Length: 57 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 884.1560 (2026)

(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).
21 C.F.R. § 884.1560: Fetal blood sampler. | Justis AI