21 C.F.R. § 884.1560

Current through October 31, 2024
Section 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).

21 C.F.R. §884.1560