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., American Laboratory Products Co., Ltd. and Zeus Scientific, Inc..

112
Total
112
Cleared
99d
Avg days
1982
Since
112 devices
25–48 of 112
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 May 12, 1998
DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM
K980337
Helix Diagnostics, Inc.
Immunology · 104d
Cleared May 12, 1998
SERAQUEST ANTI-SSA
K980810
Quest Intl., Inc.
Immunology · 70d
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 Nov 18, 1996
ORGENTEC ANTI-RNP/SM ELISA
K962057
American Laboratory Products Co., Ltd.
Immunology · 174d
Cleared Nov 18, 1996
ORGENTEC ANTI-SM ELISA
K962062
American Laboratory Products Co., Ltd.
Immunology · 174d
Cleared Nov 15, 1996
ORGENTEC ABTI-SS-BB(LA) ELISA
K962052
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-JO-1 ELISA
K962053
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-SS-A(RO) ELISA
K962054
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-SCL 70 ELISA
K962055
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Sep 30, 1996
VARELISA ANA (4) PROFILE
K963291
Elias U.S.A., Inc.
Immunology · 40d
Cleared Apr 18, 1996
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
K954814
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY
K954815
Orgentec
Immunology · 182d
Cleared Apr 18, 1996
ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY
K954829
Orgentec
Immunology · 181d
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
K954832
Orgentec
Immunology · 181d
Cleared Mar 06, 1996
THERATEST KIT (MODIFICATION)
K955481
Theratest Laboratories, Inc.
Immunology · 112d
Cleared Feb 29, 1996
QUANTA LITE SSDNA
K954380
Inova Diagnostics, Inc.
Immunology · 163d
Cleared Nov 14, 1995
THERATEST LAB, INC., EL-ANASCR KIT
K954106
Theratest Laboratories, Inc.
Immunology · 105d
Cleared Sep 26, 1995
THERATEST EL-ANA PROFILES TEST SYSTEM
K950716
Theratest Laboratories, Inc.
Immunology · 238d
Cleared May 15, 1995
MARDX ENA EIA TEST SYSTEM
K946218
Hogan & Hartson
Immunology · 145d
Cleared May 15, 1995
MARDX MITOCHONDRIA EIA TEST SYSTEM
K950110
Hogan & Hartson
Immunology · 124d
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