21 CFR 862.1280 — Radioimmunoassay, Estrone
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1280
Identification
An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CGF | Radioimmunoassay, Estrone | 1 | 4 |
