21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1725

Trypsin test system.

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21 C.F.R. § 862.1725 — Trypsin test system.

§ 862.1725 Trypsin test system. (a) Identification. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic 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 § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]

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21 C.F.R. § 862.1725
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The regulatory text of 21 C.F.R. § 862.1725 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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