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§ 862.1490 Lysozyme (muramidase) test system.

21 CFR 862.1490

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  3. Title 21
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  5. Chapter I
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  7. Part 862
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  9. Subpart B
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  11. 21 CFR 862.1490
Citation21 CFR 862.1490
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 862.1490 Lysozyme (muramidase) test system.

(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.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001]