21 CFR 862.1300 — Radioimmunoassay, Follicle-Stimulating Hormone

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1300

Identification

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

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 CodeDevice NameClassDevicesAttributes
CGJRadioimmunoassay, Follicle-Stimulating Hormone188
NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter12
Innolitics

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