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 Scimedx Corp..

75
Total
75
Cleared
139d
Avg days
1995
Since
75 devices
49–72 of 75
Cleared Feb 17, 1998
WIELISA MPO ANCA TEST SYSTEM
K974166
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167
Wieslab AB
Immunology · 104d
Cleared Feb 17, 1998
ORGENTEC ANTI-MPO (P-ANCA) ELISA
K974701
American Laboratory Products Co., Ltd.
Immunology · 71d
Cleared Feb 17, 1998
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
K974702
American Laboratory Products Co., Ltd.
Immunology · 71d
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463
Immuno Concepts, Inc.
Immunology · 75d
Cleared Feb 09, 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
K974478
Immuno Concepts, Inc.
Immunology · 75d
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 Oct 29, 1997
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
K971689
Euro-Diagnostica AB
Immunology · 175d
Cleared Oct 29, 1997
IMMUNOSCAN PR3-ANCA
K971690
Euro-Diagnostica AB
Immunology · 175d
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 Sep 30, 1996
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
K962360
Scimedx Corp.
Immunology · 103d
Cleared Aug 19, 1996
PR-3 ELISA TEST SYSTEM
K961764
Immunoprobe, Inc.
Immunology · 104d
Cleared Aug 19, 1996
MPO ELISA TEST SYSTEM
K961765
Immunoprobe, Inc.
Immunology · 104d
Cleared Jul 10, 1996
NOVA LITE ANCA
K961340
Inova Diagnostics, Inc.
Immunology · 107d
Cleared Mar 19, 1996
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
K954062
Scimedx Corp.
Immunology · 203d
Cleared Mar 19, 1996
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
K954105
Scimedx Corp.
Immunology · 201d
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