Product code DND— Clinical Toxicology
TEST, RIA, SERUM DIGOXIN
- Classification name
- Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device class
- Class 2
- Regulation
- 21 CFR 862.3300
- Advisory panel
- Clinical Toxicology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DND
FDA has cleared device under product code DND, all in 1976, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code DND
Recent clearances under product code DND
Data sourced from openFDA. This site is unofficial and independent of the FDA.