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 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
Cleared May 18, 1998
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
K981020
Zeus Scientific, Inc.
Immunology · 60d
Cleared Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196
Zeus Scientific, Inc.
Immunology · 64d
Cleared Jul 23, 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784
Zeus Scientific, Inc.
Immunology · 70d
Cleared Jun 11, 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177
Immco Diagnostics, Inc.
Immunology · 145d
Cleared Jun 03, 1997
HEMAGEN ANTI CARDIOLIPIN SCREEN
K971039
Hemagen Diagnostics, Inc.
Immunology · 74d
Cleared Oct 10, 1996
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
K962926
American Laboratory Products Co., Ltd.
Immunology · 73d
Cleared Sep 09, 1996
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469
American Laboratory Products Co., Ltd.
Immunology · 76d
Cleared May 30, 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303
Shield Diagnostics, Ltd.
Immunology · 192d
Cleared May 23, 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449
American Laboratory Products Co., Ltd.
Immunology · 176d
Cleared Feb 09, 1996
CARDIOLIPIN IGM EIA TEST SYSTEM
K952521
Immunoprobe, Inc.
Immunology · 253d
Cleared Feb 09, 1996
CARDIOLIPIN IGA EIA TEST SYSTEM
K952522
Immunoprobe, Inc.
Immunology · 253d