LEUCINE AMINOPEPTIDASE REAGENT
Device Facts
| Record ID | K844965 |
|---|---|
| Device Name | LEUCINE AMINOPEPTIDASE REAGENT |
| Applicant | Alladin Diagnostic, Inc. |
| Product Code | JGG · Clinical Chemistry |
| Decision Date | Mar 5, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1460 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A leucine aminopeptidase test system is a device intended to measure the activity of the enzyme leucine amino-peptidase in serum, plasma, and urine. Leucine aminopeptidase measurements are used in the diagnosis and treatment of liver diseases such as viral hepatitis and obstructive jaundice.
