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§ 884.1560 Fetal blood sampler.

21 CFR 884.1560

Citation21 CFR 884.1560
CorpusDaily eCFR
Displayed edition2026-04-15
Last updated2026-04-15

§ 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).