§862.1725. Trypsin test system.
21 C.F.R. § 862.1725
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 16122, May 1, 1987, unless otherwise noted.
Amendments
[52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000]