Product code DFS— Immunology

RABBIT ANTISERUM TO HUMAN IGM

Classification name
Igm, Fitc, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5550
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

Market context for product code DFS

FDA has cleared 1 device under product code DFS, 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 DFS

Recent clearances under product code DFS

Data sourced from openFDA. This site is unofficial and independent of the FDA.