CHM · Radioimmunoassay, Total Estrogens In Pregnancy
Clinical Chemistry · 21 CFR 862.1270 · Class 1
Overview
| Product Code | CHM |
|---|---|
| Device Name | Radioimmunoassay, Total Estrogens In Pregnancy |
| Regulation | 21 CFR 862.1270 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
As estrogens (total, in pregnancy) test system is a device intended to measure total estrogens in plasma, serum, and urine during pregnancy. The device primarily measures estrone plus estradiol. Measurements of total estrogens are used to aid in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (0)
No cleared devices on record.
