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Electronic Code of Federal Regulations

e-CFR data is current as of November 15, 2019

Title 21Chapter ISubchapter HPart 884Subpart B → §884.1560


Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices


§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).

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