Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
The Autoantibody Test for Skin Desmoglein 1 and Desmoglein 3 is an in vitro diagnostic device used to detect autoantibodies against desmoglein 1 (Dsg1) and desmoglein 3 (Dsg3) in patient serum, supporting the diagnosis of autoimmune blistering skin diseases such as pemphigus vulgaris and pemphigus foliaceus. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.5660 (Immunology specialty). This device is eligible for third-party 510(k) review.
Research product code NBO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NBO
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091969 | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) | Sep 02, 2010 | Substantially Equivalent | Euroimmun Us, Inc. |
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | Jun 09, 2000 | Substantially Equivalent | Rhigene, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.