DHN · Class II · 21 CFR 866.5100

FDA Product Code DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Bio-Rad, Immuno Concepts, Inc. and Zeus Scientific, Inc..

110
Total
110
Cleared
67d
Avg days
1976
Since
110 devices
25–48 of 110
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
K990915
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Dec 18, 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
K983924
Immuno Concepts, Inc.
Immunology · 44d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
K984397
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
K984398
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
K984399
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400
Bio-Rad
Immunology · 9d
Cleared Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145
Immuno Concepts, Inc.
Immunology · 263d
Cleared Feb 20, 1997
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K970198
Scimedx Corp.
Immunology · 30d
Cleared Jan 03, 1997
MICRO21 WITH NDNA
K964165
Triangle Biomedical Sciences, Inc.
Immunology · 78d
Cleared Dec 05, 1996
HEMAGEN ENA DSDNA KIT (EIA METHOD)
K962276
Hemagen Diagnostics, Inc.
Immunology · 175d
Cleared Jun 01, 1995
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979
Immuno Concepts, Inc.
Immunology · 90d
Cleared Nov 21, 1994
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096
Immuno Concepts, Inc.
Microbiology · 91d
Cleared May 20, 1993
HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
K926114
Tissue Culture Biotec, Inc.
Immunology · 168d
Cleared Jul 30, 1991
DIASTAT ANTI-JO-1 KIT
K912292
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared May 18, 1990
HEMAGEN ENA [JO-I] KIT
K902139
Hemagen Diagnostics, Inc.
Immunology · 9d
Cleared May 02, 1990
NOVA LITE(TM) ANA KSL
K901596
Inova Diagnostics, Inc.
Immunology · 27d
Cleared Apr 26, 1990
NOVA LITE(TM) ANA MK
K901595
Inova Diagnostics, Inc.
Immunology · 21d
Cleared Jan 02, 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025
Zeus Scientific, Inc.
Immunology · 14d
Cleared Sep 21, 1989
ANA ANTISERA CONTROL KIT
K894659
Lipogen, Inc.
Immunology · 59d
Cleared Nov 04, 1988
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
K884400
Immco Diagnostics, Inc.
Immunology · 16d
Cleared Mar 25, 1988
NOVA LITE(TM) DSDNA
K880742
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Feb 10, 1988
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873
Diagnostic Products Corp.
Immunology · 72d
Cleared Aug 17, 1987
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845
Bion Ent., Ltd.
Immunology · 28d
Cleared Jul 21, 1987
ANTI-DNP MICROASSAY
K872560
Diamedix Corp.
Immunology · 22d