CDC · L-Leucyl B-Naphthylamide, Leucine Aminopeptidase
Clinical Chemistry · 21 CFR 862.1460 · Class 1
Overview
| Product Code | CDC |
|---|---|
| Device Name | L-Leucyl B-Naphthylamide, Leucine Aminopeptidase |
| Regulation | 21 CFR 862.1460 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
