21 CFR 862.1725 — P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 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 Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | 1 | 0 | |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 1 | 7 |
