§884.1560. Fetal blood sampler.
21 C.F.R. § 884.1560
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.
Classification. Class II (performance standards).
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.