Code of Federal Regulations (Last Updated: April 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 884 - Obstetrical and Gynecological Devices |
Subpart B - Obstetrical and Gynecological Diagnostic Devices |
§ 884.1560 - Fetal blood sampler.
Latest version.
-
§ 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).