21 CFR 862.1505
§ 862.1505 Mucopolysaccharides (nonquantitative) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1505, § 862.1505 Mucopolysaccharides (nonquantitative) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89145
- Permanent ID
ys:prov:89145@1- SHA-256
79e0fa48c69f7512357deaf778bdf18cf42700ea53acb4ea2539d69410f3571a
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Full text
(a) Identification. A mucopolysaccharides (nonquantitative) test system is a device intended to measure the levels of mucopolysaccharides in urine. Mucopolysaccharide measurements in urine are used in the diagnosis and treatment of various inheritable disorders that affect bone and connective tissues, such as Hurler's, Hunter's, Sanfilippo's, Scheie's Morquio's and Maroteaux-Lamy syndromes.
(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.