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OEG — Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 Class II

FDA Device Classification

Classification Details

Product Code
OEG
Device Class
Class II
Regulation Number
866.5660
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Definition

The device is intended as an aid in the diagnosis of bullous pemphigoid.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193115euroimmun usEUROIMMUN Anti-BP230-CF ELISA (IgG)September 17, 2020
K083615euroimmun usEUROIMMUN ANTI BP 180-4X ELISA (IGG)March 16, 2009
K071961mbl international corporationMESACUP MODELS BP180 AND BP230 ELISA KITSAugust 25, 2008