MOB · Class II · 21 CFR 866.5660

FDA Product Code MOB: Test System, Antineutrophil Cytoplasmic Antibodies (anca)

Leading manufacturers include Inova Diagnostics, Inc., Zeus Scientific, Inc. and The Binding Site, Ltd..

74
Total
74
Cleared
139d
Avg days
1995
Since
74 devices
25–48 of 74
Cleared Nov 13, 1997
VIRGO ANCA SCREEN KIT
K973822
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
PR 3 ANTIBODY KIT
K973823
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared Nov 13, 1997
VIRGO PANCO KIT
K973824
Hemagen Diagnostics, Inc.
Immunology · 37d
Cleared May 21, 1997
ANCA COMBI DIAGNOSTIC TEST KIT
K965133
The Binding Site, Ltd.
Immunology · 149d
Cleared Apr 10, 1997
MYELOPEROXIDASE ELISA TEST SYSTEM
K964446
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449
Zeus Scientific, Inc.
Immunology · 155d
Cleared Jul 10, 1996
NOVA LITE ANCA
K961340
Inova Diagnostics, Inc.
Immunology · 107d
Cleared Mar 19, 1996
QUANTA LITE PR3
K955021
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 19, 1996
QUANTA LITE MPO
K955022
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Jan 26, 1996
VARELISA PR3-ANCA
K953586
Elias U.S.A., Inc.
Immunology · 178d
Cleared Jan 26, 1996
VARELISA MPO-ANCA
K953587
Elias U.S.A., Inc.
Immunology · 178d