Fetal blood sampler.

21 C.F.R. § 884.1560
in effectEffective: 2024-07-01
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(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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