21 CFR 862.1775
§ 862.1775 Uric acid test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1775, § 862.1775 Uric acid test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89198
- Permanent ID
ys:prov:89198@1- SHA-256
74bc65a37d9c40696e174e6746b977507d33bc32abe67ddc83eab61a9ca05c28
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Full text
(a) Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
(b) Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, 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.