DND · Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Clinical Toxicology · 21 CFR 862.3300 · Class 2
Overview
| Product Code | DND |
|---|---|
| Device Name | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. |
| Regulation | 21 CFR 862.3300 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K760077 | TEST, RIA, SERUM DIGOXIN | Smithkline Diagnostics, Inc. | Jul 16, 1976 | SESE |
Top Applicants
- Smithkline Diagnostics, Inc. — 1 clearance
