21 C.F.R. § 884.1560
Fetal blood sampler.
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).