21 CFR 862.1180 — N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1180
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.
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 |
|---|---|---|---|---|
| JKW | N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | 1 | 0 | |
| JKX | N-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin | 1 | 0 |
