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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
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Subpart B - Clinical Chemistry Test Systems |
§ 862.1500 - Malic dehydrogenase test system.
Latest version.
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§ 862.1500 Malic dehydrogenase test system.
(a) Identification. A malic dehydrogenase test system is a device that is intended to measure the activity of the enzyme malic dehydrogenase in serum and plasma. Malic dehydrogenase measurements are used in the diagnosis and treatment of muscle and liver diseases, myocardial infarctions, cancer, and blood disorders such as myelogenous (produced in the bone marrow) leukemia.
(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.
[52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000]