← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

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

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

DEVICE CLASS
Class II
REGULATION
21 CFR 866.5660
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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