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..

75
Total
75
Cleared
139d
Avg days
1995
Since
75 devices
25–48 of 75
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
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