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
49–72 of 110
Cleared Nov 21, 1983
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119
Atlantic Antibodies
Immunology · 69d
Cleared Aug 31, 1983
IDT ANA STIQ ASSAY
K832383
Intl. Diagnostic Technology
Immunology · 43d
Cleared Mar 09, 1983
AFT SYSTEM III
K830214
Calbiochem-Behring Corp.
Immunology · 44d
Cleared Dec 13, 1982
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
K822681
Amico Lab, Inc.
Microbiology · 101d
Cleared Dec 03, 1982
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
K822682
Amico Lab, Inc.
Microbiology · 91d
Cleared Oct 26, 1982
SERA FOR ANTINUCLEAR ANTIBODIES
K820945
Centers For Disease Control and Prevention
Microbiology · 203d
Cleared Sep 21, 1982
ANA HEP-2 FLUORO-KIT
K822397
Clinical Sciences, Inc.
Immunology · 42d
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
Cleared Oct 18, 1977
IFA ANTI-NDNA
K771376
Electro-Nucleonics Laboratories, Inc.
Immunology · 85d
Cleared Jun 24, 1977
ANA TEST
K771064
Gull Laboratories, Inc.
Immunology · 11d
Cleared Apr 05, 1977
NDNA IMMUNOPATH FLUORO-KIT
K770057
Clinical Sciences, Inc.
Immunology · 84d
Cleared Aug 03, 1976
TEST, DETECTION, ANTINUCLEAR ANTIBODIES
K760206
Intl. Diagnostic Technology
Immunology · 25d
Cleared Jul 26, 1976
ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP
K760209
Zeus Scientific, Inc.
Immunology · 17d
Cleared Jul 20, 1976
TEST, (IVDP) ANTINUCLEAR ANTIBODY
K760153
Zeus Scientific, Inc.
Immunology · 18d