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
49–72 of 94
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
Cleared Feb 09, 1996
CARDIOLIPIN IGG EIA TEST KIT
K952523
Immunoprobe, Inc.
Immunology · 253d
Cleared Jan 24, 1996
CARDIOLIPIN G EIA TEST SYSTEM
K946215
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN A EIA TEST SYSTEM
K946216
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN M EIA TEST SYSTEM
K946217
Hogan & Hartson
Immunology · 399d
Cleared Dec 18, 1995
REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
K952287
Reaads Medical Products, Inc.
Immunology · 216d
Cleared Oct 13, 1995
CARDIOLIPIN IGG,M,A EIA TEST SYSTEM
K951363
Immunoprobe, Inc.
Immunology · 203d
Cleared Oct 02, 1995
VARELISA CARDIOLIPIN ABS SCREEN
K951187
Elias U.S.A., Inc.
Immunology · 200d
Cleared Sep 15, 1995
CARDIOLIPIN IGG,M,A EIA TEST KIT
K952520
Immunoprobe, Inc.
Immunology · 106d
Cleared Sep 01, 1995
QUANTA LITE IGA ACA (HRP)
K953366
Inova Diagnostics, Inc.
Immunology · 45d
Cleared Aug 29, 1995
QUANTA LITE ACA SCREEN (HRP)
K953291
Inova Diagnostics, Inc.
Immunology · 46d
Cleared Jul 18, 1995
QUANTA LITE(TM) IGG (HRP)
K946034
Inova Diagnostics, Inc.
Immunology · 221d
Cleared Jul 18, 1995
QUANTA LITE ACA IGM (HRP)
K946385
Inova Diagnostics, Inc.
Immunology · 221d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)
K933784
Immco Diagnostics, Inc.
Immunology · 580d