1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
  6. Subpart B - Clinical Chemistry Test Systems
  7. 21 CFR § 862.1710
21 CFR § 862.1710
Total triiodothyronine test system
June 25, 2020
CFR

(a) Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

(b) Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 62286, Oct. 18, 2000]

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§ 862.1705 Triglyceride test system
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§ 862.1715 Triiodothyronine uptake test system

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