PVS · Fetal Blood Sampling Kit (Excludes Hiv Testing)
Obstetrics/Gynecology · 21 CFR 884.1560 · Class 2
Overview
| Product Code | PVS |
|---|---|
| Device Name | Fetal Blood Sampling Kit (Excludes Hiv Testing) |
| Regulation | 21 CFR 884.1560 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
