21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1670

Sorbitol dehydrogenase test system.

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Regulatory Text

21 C.F.R. § 862.1670 — Sorbitol dehydrogenase test system.

§ 862.1670 Sorbitol dehydrogenase test system. (a) Identification. A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders such as cirrhosis or acute hepatitis. (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]

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21 C.F.R. § 862.1670
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The regulatory text of 21 C.F.R. § 862.1670 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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