LLL · Class II · 21 CFR 866.5100

FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control

Leading manufacturers include Inova Diagnostics, Inc., Hemagen Diagnostics, Inc. and Hycor Biomedical, Inc..

182
Total
182
Cleared
110d
Avg days
1981
Since
182 devices
25–48 of 182
Cleared Jun 25, 2003
QUANTA PLEX ENA PROFILE 6
K031450
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Apr 24, 2003
QUANTA PLEX ENA PROFILE 5
K030681
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
K011140
Inova Diagnostics, Inc.
Immunology · 105d
Cleared Mar 01, 2001
ENA EIA KIT RANGE
K010146
The Binding Site, Ltd.
Immunology · 43d
Cleared Mar 01, 2001
ENA EIA KIT
K010147
The Binding Site, Ltd.
Immunology · 43d
Cleared Feb 23, 2001
ENA SCREEN EIA KIT
K010148
The Binding Site, Ltd.
Immunology · 37d
Cleared Oct 13, 2000
AUTOSTAT II ENA-6 PROFILE ELISA
K003054
Cogent Diagnotics , Ltd.
Immunology · 11d
Cleared Oct 13, 2000
AUTOSTAT II ENA-4 PROFILE ELISA
K003057
Cogent Diagnotics , Ltd.
Immunology · 11d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SSA
K000749
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SCL-70
K000750
Rhigene, Inc.
Immunology · 62d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- SSB
K000751
Rhigene, Inc.
Immunology · 62d
Cleared Apr 05, 2000
ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST
K000489
Helix Diagnostics, Inc.
Immunology · 51d
Cleared Jan 12, 2000
ENA PROFILE ELISA TEST SYSTEM
K993839
Trinity Biotech USA
Immunology · 61d
Cleared Jan 11, 2000
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
K993971
Micro Detect, Inc.
Immunology · 49d
Cleared Jan 11, 2000
MDI SM TEST
K994029
Micro Detect, Inc.
Immunology · 46d
Cleared Jun 17, 1999
QUANTA LITE ANA ELISA
K991657
Inova Diagnostics, Inc.
Immunology · 35d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-B/LA ELISA
K990626
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-A/RO ELISA
K990627
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SCL-70 ELISA
K990797
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-JO-1 ELISA
K990798
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Dec 28, 1998
AUTOSTAT II ENA SCREEN ELISA
K983921
Cogent Diagnotics , Ltd.
Immunology · 54d
Cleared Dec 22, 1998
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
K984462
Bio-Rad
Immunology · 6d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
K983376
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983423
Zeus Scientific, Inc.
Immunology · 50d