NBO · Class II · 21 CFR 866.5660

FDA Product Code NBO: Autoantibodies, Skin (desmoglein 1 And Desmoglein 3)

Leading manufacturers include Rhigene, Inc. and Euroimmun Us, Inc..

2
Total
2
Cleared
278d
Avg days
2000
Since

FDA 510(k) Cleared Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) Devices (Product Code NBO)

2 devices
1–2 of 2
Cleared Sep 02, 2010
EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)
K091969
Euroimmun Us, Inc.
Immunology · 428d
Cleared Jun 09, 2000
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
K000336
Rhigene, Inc.
Immunology · 127d

About Product Code NBO - Regulatory Context