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., Zeus Scientific, Inc. and Inova Diagnostics, Inc..

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 Feb 07, 2014
QUANTA FLASH CENTROMERE
K123880
Inova Diagnostics, Inc.
Immunology · 417d
Cleared Oct 26, 2004
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102
Immco Diagnostics, Inc.
Immunology · 182d
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 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 Jul 23, 1999
RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
K992041
Immuno Concepts, Inc.
Immunology · 36d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
K983378
Zeus Scientific, Inc.
Immunology · 54d
Cleared Mar 06, 1997
ELIAS ANA-HEP-2
K964385
Elias U.S.A., Inc.
Immunology · 122d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
K962450
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Sep 30, 1996
VARELISA ANA (4) PROFILE
K963291
Elias U.S.A., Inc.
Immunology · 40d
Cleared Feb 29, 1996
QUANTA LITE SSDNA
K954380
Inova Diagnostics, Inc.
Immunology · 163d
Cleared Apr 17, 1995
VARELISA ANA-4 SCREEN
K951186
Elias U.S.A., Inc.
Immunology · 32d
Cleared Apr 17, 1995
VARELISA ANA PROFILE
K951205
Elias U.S.A., Inc.
Immunology · 31d
Cleared Apr 17, 1995
VARELISA HISTONE ANTIBODIES
K951207
Elias U.S.A., Inc.
Immunology · 31d
Cleared Jan 20, 1995
ANTI-HISTONE ANIBODY TEST
K943585
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Dec 22, 1994
VARELISA RNP-SM ANTIBODIES
K944167
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA LA (SS-B) ANTIBODIES
K944168
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA RO (SS-A) ANTIBODIES
K944169
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SM ANTIBODIES
K944170
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA CENTROMERE ANTIBODIES
K944171
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SCL-70 ANTIBODIES
K944172
Elias U.S.A., Inc.
Immunology · 118d

About Product Code LJM - Regulatory Context