Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES
/ Subpart B - Obstetrical and Gynecological Diagnostic Devices / § 884.1560 Fetal blood sampler.
§ 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).