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 Diamedix Corp..

182
Total
182
Cleared
110d
Avg days
1981
Since
182 devices
49–72 of 182
Cleared Nov 18, 1998
THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
K983425
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC
K983426
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983464
Zeus Scientific, Inc.
Immunology · 48d
Cleared Oct 07, 1998
QUANTA LITE CHROMATIN ELISA
K982603
Inova Diagnostics, Inc.
Immunology · 72d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/4
K982150
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/5
K982622
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Jul 29, 1998
QUANTA LITE TPO ELISA
K981857
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Jun 15, 1998
SERAQUEST ANTI-SSB
K980639
Quest Intl., Inc.
Immunology · 116d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759
Diamedix Corp.
Immunology · 55d
Cleared Apr 08, 1997
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
K964787
Mardx Diagnostics, Inc.
Immunology · 130d
Cleared Apr 08, 1997
IS-ANTI-SSA TEST SYSTEM
K970218
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM TEST SYSTEM
K970220
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-JO-1 TEST SYSTEM
K970228
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SSB TEST SYSTEM (720-260)
K970237
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM/RNP (720-270)
K970238
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SCL-70 TEST SYSTEM (720-280)
K970239
Diamedix Corp.
Immunology · 77d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
K962728
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Sep 13, 1996
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
K963275
Immuno Concepts, Inc.
Immunology · 24d