REAGENT SYSTEM 153-UV
Device Facts
| Record ID | K770519 |
|---|---|
| Device Name | REAGENT SYSTEM 153-UV |
| Applicant | Sigma Chemical Co. |
| Product Code | JKG · Clinical Chemistry |
| Decision Date | Jun 3, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1420 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An isocitric dehydrogenase test system is a device intended to measure the activity of the enzyme isocitric dehydrogenase in serum and plasma. Isocitric dehydrogenase measurements are used in the diagnosis and treatment of liver disease such as viral hepatitis, cirrhosis, or acute inflammation of the biliary tract; pulmonary disease such as pulmonary infarction (local arrest or sudden insufficiency of the blood supply to the lungs), and diseases associated with pregnancy.
