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 Immco Diagnostics, Inc..

75
Total
75
Cleared
139d
Avg days
1995
Since
75 devices
49–72 of 75
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
Cleared Jan 26, 1996
VARELISA MPO-ANCA
K953587
Elias U.S.A., Inc.
Immunology · 178d
Cleared Mar 06, 1995
DIASTAT ANTI-PR3 (C-ANCA) KIT
K942813
Shield Diagnostics, Ltd.
Immunology · 265d
Cleared Mar 06, 1995
DIASTAT ANTI-MPO (PANCA) KIT
K943630
Shield Diagnostics, Ltd.
Immunology · 223d