OEG · Class II · 21 CFR 866.5660

FDA Product Code OEG: Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230

The Device Is Intended As An Aid In The Diagnosis Of Bullous Pemphigoid.

Leading manufacturers include Euroimmun Us, Inc..

3
Total
3
Cleared
271d
Avg days
2008
Since

FDA 510(k) Cleared Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 Devices (Product Code OEG)

3 devices
1–3 of 3
Cleared Sep 17, 2020
EUROIMMUN Anti-BP230-CF ELISA (IgG)
K193115
Euroimmun Us, Inc.
Immunology · 310d
Cleared Mar 16, 2009
EUROIMMUN ANTI BP 180-4X ELISA (IGG)
K083615
Euroimmun Us, Inc.
Immunology · 98d

About Product Code OEG - Regulatory Context