21 CFR 862.1345
§ 862.1345 Glucose test system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 862.1345, § 862.1345 Glucose test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89109
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Full text
(a) Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
(b) Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.