COULTER DART ALT (GPT) REAGENT
Device Facts
| Record ID | K905767 |
|---|---|
| Device Name | COULTER DART ALT (GPT) REAGENT |
| Applicant | Coulter Electronics, Inc. |
| Product Code | CKA · Clinical Chemistry |
| Decision Date | Jan 25, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1030 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
