21 CFR 862.1645
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1645, § 862.1645 Urinary protein or albumin (nonquantitative) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89177
- Permanent ID
ys:prov:89177@1- SHA-256
1cb787464c4c622cfca399c8f39838329e9e21a90ced6d49b224a0fc3a059576
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Full text
(a) Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
(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.