LCW · Radioimmunoassay, Digitoxin (125-I)
Clinical Toxicology · 21 CFR 862.3300 · Class 2
Overview
| Product Code | LCW |
|---|---|
| Device Name | Radioimmunoassay, Digitoxin (125-I) |
| 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 |
|---|---|---|---|---|
| K834080 | MATCHED COMPONENT SET FOR DIGITOXIN | Cambridge Medical Technology | Feb 4, 1984 | SESE |
| K802461 | ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Oct 31, 1980 | SESE |
| K780766 | (125 I) DIGITOXIN RIA KIT | Diagnostic Products Corp. | Jul 27, 1978 | SESE |
Top Applicants
- Cambridge Medical Technology — 1 clearance
- Diagnostic Products Corp. — 1 clearance
- Immunotech Corp. — 1 clearance
