OEG · Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | OEG |
|---|---|
| Device Name | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | Euroimmun Us, Inc. | Sep 17, 2020 | SESE |
| K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | Euroimmun Us, Inc. | Mar 16, 2009 | SESE |
| K071961 | MESACUP MODELS BP180 AND BP230 ELISA KITS | Mbl International Corporation | Aug 25, 2008 | SESE |
Top Applicants
- Euroimmun Us, Inc. — 2 clearances
- Mbl International Corporation — 1 clearance
