DPG · Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Clinical Toxicology · 21 CFR 862.3300 · Class 2
Overview
| Product Code | DPG |
|---|---|
| Device Name | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K935229 | OPUS DIGITOXIN | Pb Diagnostic Systems, Inc. | Dec 22, 1993 | SESE |
| K812129 | COAT-A-COUNT DIGITOXIN RIA KIT | Diagnostic Products Corp. | Aug 13, 1981 | SESE |
| K780075 | RIALYZE DIGOXIN | Miles Laboratories, Inc. | Feb 28, 1978 | SESE |
Top Applicants
- Diagnostic Products Corp. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Pb Diagnostic Systems, Inc. — 1 clearance
