Product code DFB— Immunology
FERRITIN IMMUNORADIOMETRIC ASSAY KIT
- Classification name
- Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DFB
FDA has cleared device under product code DFB, all in 1983, 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 DFB
Recent clearances under product code DFB
Data sourced from openFDA. This site is unofficial and independent of the FDA.