21 CFR § 884.1560 Obstetrical and Gynecological Devices

§ 884.1560 Fetal blood sampler.

Current through Sep 8, 2026 · Read all of Part 884

(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).

← § 884.1550 Amniotic fluid sampler (amniocentesis tray).§ 884.1600 Transabdominal amnioscope (fetoscope) and accessories. →