ACA(R) DIGITOXIN (DGTX) METHOD
Device Facts
| Record ID | K891094 |
|---|---|
| Device Name | ACA(R) DIGITOXIN (DGTX) METHOD |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | LFM · Clinical Toxicology |
| Decision Date | Apr 26, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.
