Product code NBO— Immunology
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
- Classification name
- Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code NBO
FDA has cleared devices under product code NBO between 2000 and 2010, 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
- 2010
- 2000
Top applicants under product code NBO
Recent clearances under product code NBO
Data sourced from openFDA. This site is unofficial and independent of the FDA.