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
73–96 of 110
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 Nov 05, 1982
FLOUROSET IMMUNOFLUORESCENT ANTIBODY
K823055
Immulok, Inc.
Immunology · 18d
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 Sep 17, 1982
ANTINUCLEAR ANTOBODY CELL SUBSTRATE
K822607
Immulok, Inc.
Immunology · 21d
Cleared Feb 12, 1982
ANA TEST (MOUSE LIVER SUBSTRATE)
K820265
Meloy Laboratories, Inc.
Immunology · 10d
Cleared Jan 18, 1982
QUANTAFLUOR FLUORESCENT TEST REAGENTS
K813592
Kallestad Laboratories, Inc.
Immunology · 21d
Cleared Sep 01, 1981
CRITHIDNA ANTI-DNA TEST KIT
K812314
Antibodies, Inc.
Immunology · 15d
Cleared Jul 10, 1981
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
K811714
Scripps-Miles, Inc.
Immunology · 23d
Cleared May 01, 1981
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
K810985
Immuno-Products Industries
Immunology · 18d
Cleared Apr 23, 1981
ANA TEST KIT
K811022
Immuno-Diagnostic Products, Inc.
Immunology · 8d
Cleared Feb 25, 1981
CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
K810301
Immuno Concepts, Inc.
Immunology · 21d
Cleared Feb 09, 1981
SCRIPPSERA ANA REFERENCE CONTROL SERA
K810081
Scripps-Miles, Inc.
Immunology · 27d
Cleared Jan 29, 1981
K/K (ASMA/ANA) UNIVERSAL BIOPAK
K802299
Bioware Products
Immunology · 132d
Cleared Jan 26, 1981
ANA-IFA TEST SYSTEM
K803276
Immuno Concepts, Inc.
Immunology · 28d
Cleared Jan 05, 1981
TEST KIT FOR DETECTION OF ANTINUCLEAR
K802527
Bartels & Stout, Inc.
Immunology · 82d
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 Nov 13, 1979
ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
K791928
Keith E. Abbott
Immunology · 47d
Cleared Oct 30, 1979
ANTI NUCLEAR ANTIBODY TEST
K791995
Meda Stat Diagnostics, Inc.
Immunology · 27d
Cleared Sep 24, 1979
ANTI-NUCLEAR ANTIBODY TEST
K791493
Meloy Laboratories, Inc.
Immunology · 53d
Cleared Apr 23, 1979
AUTOANTIBODY REAGENTS, AFT SYSTEM II
K790280
Calbiochem-Behring Corp.
Immunology · 69d