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
25–48 of 75
Cleared Jul 02, 2004
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
K041043
Pharmacia Deutschland GmbH
Immunology · 71d
Cleared Jun 16, 2004
VARELISA MPO ANCA, MODEL 17648/17696
K041040
Sweden Diagnostics (Germany) GmbH
Immunology · 55d
Cleared Apr 05, 2004
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
K040111
Zeus Scientific, Inc.
Immunology · 76d
Cleared Apr 02, 2004
MESACUP TEST PR-3
K040711
Rhigene, Inc.
Immunology · 15d
Cleared Mar 22, 2004
MESACUP TEST MPO, MODEL 11053
K040586
Rhigene, Inc.
Immunology · 17d
Cleared Nov 14, 2001
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
K013283
Immuno Concepts, Inc.
Immunology · 43d
Cleared Nov 14, 2001
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
K013285
Immuno Concepts, Inc.
Immunology · 43d
Cleared Mar 16, 2001
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
K010287
Scimedx Corp.
Immunology · 44d
Cleared Mar 07, 2001
SCIMEDX PHASE II MPO IGG ANTIBODY EIA
K010289
Scimedx Corp.
Immunology · 35d
Cleared Sep 28, 2000
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215
Cogent Diagnotics , Ltd.
Immunology · 66d
Cleared Aug 30, 2000
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
K001127
The Binding Site, Ltd.
Immunology · 149d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
K990796
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
K984516
Zeus Scientific, Inc.
Immunology · 24d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
K984315
Zeus Scientific, Inc.
Immunology · 14d
Cleared Nov 30, 1998
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
K982898
Immco Diagnostics, Inc.
Immunology · 105d
Cleared Nov 30, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K984034
Zeus Scientific, Inc.
Immunology · 18d
Cleared Nov 18, 1998
IS-ANTI-MPO IGG ELISA TEST SYSTEM
K983390
Columbia Bioscience, Inc.
Immunology · 54d
Cleared Nov 18, 1998
IS-ANTI-PR3 IGG ELISA TEST SYSTEM
K983740
Columbia Bioscience, Inc.
Immunology · 27d
Cleared Jul 22, 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750
Wieslab AB
Immunology · 65d
Cleared Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
K981030
The Binding Site, Ltd.
Immunology · 123d
Cleared Jun 19, 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
K981328
Inova Diagnostics, Inc.
Immunology · 67d
Cleared Jun 19, 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
K981330
Inova Diagnostics, Inc.
Immunology · 67d