21 CFR 862.1400
§ 862.1400 Hydroxyproline test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1400, § 862.1400 Hydroxyproline test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89124
- Permanent ID
ys:prov:89124@1- SHA-256
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Full text
(a) Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.
(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.