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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1300

§ 862.1300. Follicle-stimulating hormone test system.

79 words·~1 min read·/us/cfr/t21/s§ 862.1300·

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(a)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.
(b)Classification. 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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]
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