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 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
Cleared Mar 09, 1983
AFT SYSTEM III
K830214
Calbiochem-Behring Corp.
Immunology · 44d
Cleared Jan 18, 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592
Kallestad Laboratories, Inc.
Immunology · 21d
Cleared Feb 25, 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301
Immuno Concepts, Inc.
Immunology · 21d
Cleared Jan 26, 1981
ANA-IFA TEST SYSTEM
K803276
Immuno Concepts, Inc.
Immunology · 28d
Cleared May 14, 1980
ANATON
K801046
Armkel, LLC
Immunology · 9d
Cleared Nov 30, 1979
LAB-TEK ANA TEST KIT
K792184
Miles Laboratories, Inc.
Immunology · 32d
Cleared Apr 23, 1979
AUTOANTIBODY REAGENTS, AFT SYSTEM II
K790280
Calbiochem-Behring Corp.
Immunology · 69d
Cleared Jan 17, 1979
TEST KIT, IIF-ANA
K782048
Medica Corp.
Immunology · 40d
Cleared Sep 07, 1978
FLUORESCENT ANTI-NATIVE DNA TEST
K780899
Kallestad Laboratories, Inc.
Immunology · 97d
Cleared Feb 13, 1978
TEST SYS. FOR NDNA ANTIBODY DETERM.
K780178
Zeus Scientific, Inc.
Immunology · 10d
Cleared Feb 07, 1978
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER
K780161
Zeus Scientific, Inc.
Immunology · 7d