21 CFR 862.3320 — Antiserum, Digoxin
Clinical Toxicology (TX) · Subpart D—Clinical Toxicology Test Systems · § 862.3320
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DKA | Antiserum, Digoxin | 2 | 3 | 3rd Party |
| DNJ | Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. | 2 | 2 | 3rd Party |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 2 | 8 | 3rd Party |
| DNQ | Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Coated Tubes Sep. | 2 | 0 | 3rd Party |
| DNS | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Double Label Sep. | 2 | 0 | 3rd Party |
| DOA | Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep. | 2 | 1 | 3rd Party |
| DOG | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol | 2 | 5 | 3rd Party |
| DON | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. | 2 | 17 | 3rd Party |
| DOR | Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep. | 2 | 1 | 3rd Party |
| DOY | Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | 2 | 5 | 3rd Party |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 2 | 10 | 3rd Party |
| DPD | Radioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep. | 2 | 1 | 3rd Party |
| DPI | Radioimmunoassay, Digoxin (125-I), Bovine Antibody, Charcoal Sep. | 2 | 0 | 3rd Party |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 2 | 14 | 3rd Party |
| KXT | Enzyme Immunoassay, Digoxin | 2 | 85 | 3rd Party |
| LAN | Enzyme Immunoassay, N-Acetylprocainamide | 2 | 21 | 3rd Party |
| LAR | Enzyme Immunoassay, Procainamide | 2 | 25 | 3rd Party |
| LBZ | Enzyme Immunoassay, Quinidine | 2 | 27 | 3rd Party |
| LCS | Radioimmunoassay, Digoxin (125-I) | 2 | 15 | 3rd Party |
| LCT | Radioimmunoassay, Digoxin (3-H) | 2 | 0 | 3rd Party |
