21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1180

Chymotrypsin test system.

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21 C.F.R. § 862.1180 — Chymotrypsin test system.

§ 862.1180 Chymotrypsin test system. (a) Identification. A chymotrypsin test system is a device intended to measure the activity of the enzyme chymotrypsin in blood and other body fluids and in feces. Chymotrypsin measurements are used in the diagnosis and treatment of pancreatic exocrine insufficiency. (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 2305, Jan. 14, 2000]

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21 C.F.R. § 862.1180
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The regulatory text of 21 C.F.R. § 862.1180 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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