21 CFR 884.1560 — Sampler, Blood, Fetal
Obstetrics/Gynecology (OB) · Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices · § 884.1560
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HGW | Sampler, Blood, Fetal | 2 | 4 | 3rd Party |
| PVS | Fetal Blood Sampling Kit (Excludes Hiv Testing) | 2 | 0 |
