21 CFR 862.1490
§ 862.1490 Lysozyme (muramidase) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1490, § 862.1490 Lysozyme (muramidase) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89141
- Permanent ID
ys:prov:89141@1- SHA-256
57ca2d9580e1c672fa3dba365d05c6d250f56830ce20cb5864492b8029ba8bd6
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Full text
(a) Identification. A lysozyme (muramidase) test system is a device intended to measure the activity of the bacteriolytic enzyme lysozyme (muramidase) in serum, plasma, leukocytes, and urine. Lysozyme measurements are used in the diagnosis and treatment of monocytic leukemia and kidney disease.
(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.