21 CFR 862.1435
§ 862.1435 Ketones (nonquantitative) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1435, § 862.1435 Ketones (nonquantitative) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89130
- Permanent ID
ys:prov:89130@1- SHA-256
6f531aeae2f83f0edc4565c68e5d56dacc92f138c49396a3d2cde85a15489f15
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Full text
(a) Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.