ROCHE COBAS INTEGRA REAGENT CASSETTES
Device Facts
| Record ID | K954992 |
|---|---|
| Device Name | ROCHE COBAS INTEGRA REAGENT CASSETTES |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CIT · Clinical Chemistry |
| Decision Date | Jan 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
