DNJ — Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep. Class II
FDA product code DNJ covers "Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DNJ
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No