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
97–110 of 110
Cleared Mar 15, 1979
ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
K790252
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Jan 17, 1979
TEST KIT, IIF-ANA
K782048
Medica Corp.
Immunology · 40d
Cleared Jan 03, 1979
FIAX TEST KIT
K782041
Idt, A Division of Whittaker M.A. Bioproducts
Immunology · 27d
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 Jan 20, 1978
FIAX TEST FOR ANTI-RUBELLA ANTIBODY
K772219
Idt, A Division of Whittaker M.A. Bioproducts
Immunology · 46d
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 Oct 21, 1976
INDIRECT FLUORESCENT (IFA-ANA)
K760681
Wampole Laboratories
Immunology · 31d
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