21 CFR 862.1485 — Radioimmunoassay, Luteinizing Hormone
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1485
Identification
A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.
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 |
|---|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 143 | |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 1 | 6 |
