Product code DGE— Immunology
OPUS FERRITIN TEST SYSTEM
- Classification name
- Igd, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code DGE
FDA has cleared devices under product code DGE between 1987 and 1992, filed by 2 applicant companies. 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.
Clearances per year
- 1992
- 1987
Top applicants under product code DGE
Recent clearances under product code DGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.