Product code OEG— Immunology

EUROIMMUN ANTI BP 180-4X ELISA (IGG)

Classification name: Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Total cleared: 3
First cleared: 2008-08-25
Most recent: 2020-09-17

FDA classification definition

“The device is intended as an aid in the diagnosis of bullous pemphigoid.”
— U.S. Food and Drug Administration, device classification record for product code OEG under 21 CFR 866.5660, via openFDA

Market context for product code OEG

FDA has cleared 3 devices under product code OEG between 2008 and 2020, filed by 2 applicant companies. 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.

Clearances per year

20201 clearance
20091 clearance
20081 clearance

Top applicants under product code OEG

Euroimmun Us, Inc.2 clearances
Mbl International Corporation1 clearance

Recent clearances under product code OEG

K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG)Euroimmun Us, Inc.·2020-09-17
K083615 — EUROIMMUN ANTI BP 180-4X ELISA (IGG)Euroimmun Us, Inc.·2009-03-16
K071961 — MESACUP MODELS BP180 AND BP230 ELISA KITSMbl International Corporation·2008-08-25

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