Electronic Code of Federal Regulations
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e-CFR data is current as of July 13, 2020 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1325 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1325 Gastrin test system.
(a) Identification. A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).
(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]