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Code of Federal Regulations Title 21. Food and Drugs § 21.862.1325 Gastrin test system

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.862.1325 Gastrin test system - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-862-1325/

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