21 CFR 862.1625 — Radioimmunoassay, Prolactin (Lactogen)

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1625

Identification

A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

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
CFTRadioimmunoassay, Prolactin (Lactogen)180
Innolitics

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