Product code DFF— Immunology
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT
- Classification name
- Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5080
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DFF
FDA has cleared device under product code DFF, all in 1987, 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 DFF
Recent clearances under product code DFF
Data sourced from openFDA. This site is unofficial and independent of the FDA.