21 CFR 862.3300 — Antiserum, Digitoxin
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3300
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DKQ | Antiserum, Digitoxin | 2 | 0 | 3rd Party |
| DND | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 2 | 1 | 3rd Party |
| DNW | Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep. | 2 | 0 | 3rd Party |
| DOB | Radioimmunoassay, Digitoxin (3-H) | 2 | 0 | 3rd Party |
| DOW | Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Coated Tube | 2 | 0 | 3rd Party |
| DPG | Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 2 | 3 | 3rd Party |
| DPL | Radioimmunoassay, Digitoxin (125-I), Bovine Antibody, Charcoal Sep. | 2 | 0 | 3rd Party |
| LCW | Radioimmunoassay, Digitoxin (125-I) | 2 | 3 | 3rd Party |
| LFM | Enzyme Immunoassay, Digitoxin | 2 | 20 | 3rd Party |
