21 CFR 862.1580
§ 862.1580 Phosphorus (inorganic) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1580, § 862.1580 Phosphorus (inorganic) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89162
- Permanent ID
ys:prov:89162@1- SHA-256
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Full text
(a) Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
(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 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.