COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
Device Facts
| Record ID | K936131 |
|---|---|
| Device Name | COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | LGR · Clinical Toxicology |
| Decision Date | Mar 11, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3350 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.
