MID · Class II · 21 CFR 866.5660

FDA Product Code MID: System, Test, Anticardiolipin Immunological

Leading manufacturers include Zeus Scientific, Inc., Inova Diagnostics, Inc. and Corgenix, Inc..

94
Total
94
Cleared
155d
Avg days
1991
Since
94 devices
25–48 of 94
Cleared Mar 13, 2002
QACA IGG/IGM ELISA KIT
K020241
Cheshire Diagnostics , Ltd.
Immunology · 49d
Cleared Mar 06, 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156
Axis-Shield Diagnostics, Ltd.
Immunology · 48d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450
Diamedix Corp.
Immunology · 86d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018
Corgenix, Inc.
Immunology · 13d
Cleared Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K012567
Corgenix, Inc.
Immunology · 14d
Cleared Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053
Diamedix Corp.
Immunology · 49d
Cleared Nov 27, 2000
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069
Quest Intl., Inc.
Immunology · 56d
Cleared Aug 21, 2000
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
K001981
Axis-Shield , Ltd.
Immunology · 53d
Cleared Jun 09, 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
K001574
Axis-Shield
Immunology · 18d
Cleared Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920
Corgenix, Inc.
Immunology · 35d
Cleared Feb 01, 2000
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
K993085
Cogent Diagnotics , Ltd.
Immunology · 139d
Cleared Nov 24, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449
Cogent Diagnotics , Ltd.
Immunology · 125d
Cleared Sep 21, 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440
Cogent Diagnotics , Ltd.
Immunology · 61d
Cleared Mar 18, 1999
ACL/APS FACS KIT
K984102
Louisville Apl Diagnostics, Inc.
Immunology · 121d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
K983694
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
K983695
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
K983696
The Binding Site, Ltd.
Immunology · 107d
Cleared Dec 22, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
K984173
Zeus Scientific, Inc.
Immunology · 32d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
K984175
Zeus Scientific, Inc.
Immunology · 27d
Cleared Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
K984347
Zeus Scientific, Inc.
Immunology · 13d
Cleared Jun 02, 1998
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
K981014
Zeus Scientific, Inc.
Immunology · 76d
Cleared Jun 02, 1998
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
K981021
Zeus Scientific, Inc.
Immunology · 75d