DOA · Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Clinical Toxicology · 21 CFR 862.3320 · Class 2
Overview
| Product Code | DOA |
|---|---|
| Device Name | Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. |
| Regulation | 21 CFR 862.3320 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K032291 | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | Linde Medical Sensors AG | Aug 24, 2004 | SESE |
Top Applicants
- Linde Medical Sensors AG — 1 clearance
