LKJ · Class II · 21 CFR 866.5100

FDA Product Code LKJ: Antinuclear Antibody, Antigen, Control

Leading manufacturers include Bio-Rad, Elias U.S.A., Inc. and Zeus Scientific, Inc..

50
Total
50
Cleared
88d
Avg days
1983
Since
50 devices
25–48 of 50
Cleared Dec 15, 1995
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
K954700
Helix Diagnostics, Inc.
Immunology · 64d
Cleared Dec 15, 1995
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
K954723
Helix Diagnostics, Inc.
Immunology · 63d
Cleared Nov 15, 1993
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876
Shield Diagnostics, Ltd.
Immunology · 154d
Cleared Sep 24, 1993
SYNELISA CENP-B ANTIBODIES
K931255
Elias U.S.A., Inc.
Immunology · 196d
Cleared Aug 23, 1993
SYLNELISA HISTONE ANTIBODIES
K932302
Elias U.S.A., Inc.
Immunology · 103d
Cleared Aug 23, 1993
RHEUMELISA II HISTONE ANTIBODY TEST KIT
K932679
Biowhittaker Molecular Applications, Inc.
Immunology · 82d
Cleared Dec 01, 1992
SYN ELISA DSDNA ANTIBODIES
K921132
Elias U.S.A., Inc.
Immunology · 266d
Cleared May 22, 1992
THE THERATEST EL-ANA PROFILES
K914454
Theratest Laboratories, Inc.
Immunology · 228d
Cleared May 01, 1992
AUTOSTAT(TM) ANTI-DSNA
K913342
Cogent Diagnotics , Ltd.
Immunology · 280d
Cleared Mar 18, 1992
ENCORE SCL-70
K920150
Clark Laboratories, Inc.
Immunology · 65d
Cleared Feb 11, 1992
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
K914550
Diagnostic Resources, Inc.
Immunology · 123d
Cleared Jul 30, 1991
DISTAT ANTI-SCL-70 KIT
K912291
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Aug 02, 1989
SERATEST ENA [SCL-70] KIT
K894411
Hemagen Diagnostics, Inc.
Immunology · 16d
Cleared Jul 14, 1989
QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA
K893896
Biostar Medical Products, Inc.
Immunology · 45d
Cleared Jun 23, 1989
SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM
K893897
Biostar Medical Products, Inc.
Immunology · 24d
Cleared Apr 14, 1989
ANA-5 AUTOANTIBODY PROFILE KIT
K885224
Autoimmunity Diagnostics Corp.
Immunology · 115d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883
Immco Diagnostics, Inc.
Immunology · 44d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Sep 22, 1988
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY
K882740
Lipogen, Inc.
Immunology · 83d
Cleared Nov 04, 1987
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115
Sigma Diagnostics, Inc.
Immunology · 26d
Cleared Sep 22, 1987
ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS
K873249
Cytotech, Inc.
Immunology · 36d
Cleared Mar 12, 1987
ANA TEST KIT
K864668
Val Tech Diagnostics, Inc.
Immunology · 100d
Cleared Aug 06, 1986
KALLESTAD SM/RNP TEST REAGENT
K862313
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Oct 25, 1984
SERATEST DNA DETERMINATION
K842563
Seragen Diagnostics, Inc.
Immunology · 115d