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 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 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 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 Jul 21, 1987
ANTI-DNP MICROASSAY
K872560
Diamedix Corp.
Immunology · 22d
Cleared Oct 24, 1986
ANTI-DNA MICROASSAY
K863717
Diamedix Corp.
Immunology · 31d
Cleared Feb 26, 1986
AFT-HEP SYSTEM
K860183
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Nov 01, 1984
COLORZYME NDNA TEST SYSTEM
K843225
Immuno Concepts, Inc.
Immunology · 77d
Cleared Oct 05, 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 39d
Cleared Jun 22, 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776
Behring Diagnostics, Inc.
Immunology · 53d
Cleared Apr 25, 1984
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127
Electro-Nucleonics Laboratories, Inc.
Immunology · 40d