Luteinizing hormone test system.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Chemistry Test Systems
  8. Luteinizing hormone test system.

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§ 862.1485 Luteinizing hormone test system.

(a) 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.

(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 2307, Jan. 14, 2000]


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