Code of Federal Regulations · Section

§ 884.1560 — Fetal Blood Sampler

21 C.F.R. § 884.1560

View:

(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).

Authorizing Statute