21 CFR 862.1540
§ 862.1540 Osmolality test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1540, § 862.1540 Osmolality test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89153
- Permanent ID
ys:prov:89153@1- SHA-256
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Full text
(a) Identification. An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.
(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.