LJM · Class II · 21 CFR 866.5100

FDA Product Code LJM: Antinuclear Antibody (enzyme-labeled), Antigen, Controls

Leading manufacturers include Elias U.S.A., Inc., Biohytech International, Inc. and American Laboratory Products Co., Ltd..

112
Total
112
Cleared
99d
Avg days
1982
Since

FDA 510(k) Cleared Antinuclear Antibody (enzyme-labeled), Antigen, Controls Devices (Product Code LJM)

112 devices
1–24 of 112
Cleared Nov 27, 2018
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353
Phadia AB
Immunology · 90d
Cleared Mar 11, 2016
ImmuLisa Enhanced Centromere Antibody ELISA
K151559
Immco Diagnostics, Inc.
Immunology · 275d
Cleared Oct 30, 2014
ELIA SCL-70S IMMUNOASSAY
K140493
Phadia GmbH
Immunology · 245d
Cleared Feb 07, 2014
QUANTA FLASH CENTROMERE
K123880
Inova Diagnostics, Inc.
Immunology · 417d
Cleared Jan 28, 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330
Gold Standard Diagnostics
Immunology · 265d
Cleared Jul 15, 2013
ANA SCREEN ELISA (IGG)
K131185
Euroimmun US
Immunology · 80d
Cleared Mar 13, 2009
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188
Phadia US, Inc.
Immunology · 135d
Cleared Jun 28, 2005
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967
Sweden Diagnostics (Germany) GmbH
Immunology · 71d
Cleared Apr 26, 2005
VARELISA RECOMBI ANA PROFILE, MODEL 18496
K050625
Sweden Diagnostics (Germany) GmbH
Immunology · 46d
Cleared Oct 26, 2004
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Jun 23, 2004
AESKULISA ANA HEP-2
K040953
Aesku, Inc.
Immunology · 72d
Cleared May 14, 2004
VARELISA HISTONE ANTIBODIES, MODEL 16496
K040810
Pharmacia Deutschland GmbH
Immunology · 46d
Cleared Mar 11, 2004
EL-ANA PROFILES: ANTI-CHROMATIN
K040291
Theratest Laboratories, Inc.
Immunology · 34d
Cleared Mar 04, 2004
MESACUP-2 TEST CENP-B
K040200
Rhigene, Inc.
Immunology · 35d
Cleared May 02, 2003
ANA DETECT
K030929
Orgentec Diagnostika GmbH
Immunology · 39d
Cleared Feb 06, 2003
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
K024031
Theratest Laboratories, Inc.
Immunology · 62d
Cleared Jul 05, 2002
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018
Rhigene, Inc.
Immunology · 15d
Cleared Feb 15, 2001
ANA EIA DIAGNOSTIC TEST KIT
K004019
The Binding Site, Ltd.
Immunology · 50d
Cleared Jan 22, 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559
Theratest Laboratories, Inc.
Immunology · 26d
Cleared May 22, 2000
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K000879
Zeus Scientific, Inc.
Immunology · 63d
Cleared May 22, 2000
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K000880
Zeus Scientific, Inc.
Immunology · 63d
Cleared Apr 07, 2000
MDI SCL-70 TEST
K000934
Micro Detect, Inc.
Immunology · 15d
Cleared Jan 18, 2000
RHIGENE ANA ELISA TEST SYSTEM
K994071
Rhigene, Inc.
Immunology · 47d

About Product Code LJM - Regulatory Context