DDK — Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control Class I

FDA Device Classification

FDA product code DDK covers "Beta-2-Glycoprotein Iii, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5440. Submissions are reviewed by the Immunology panel.

Classification Details

Product Code
DDK
Device Class
Class I
Regulation Number
866.5440
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No