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 Jun 09, 1987
CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
K871801
Cytotech, Inc.
Immunology · 32d
Cleared Apr 29, 1987
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
K871144
Vitrotec Laboratories, Inc.
Immunology · 37d
Cleared Apr 20, 1987
DUAL SUBSTRATE ANA
K871395
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Mar 17, 1987
HISTONES EIA DIAGNOSTIC KIT
K870458
Biohytech International, Inc.
Immunology · 55d
Cleared Mar 10, 1987
RAT LIVER NUCLEI TEST SYSTEM
K870732
Val Tech Diagnostics, Inc.
Immunology · 13d
Cleared Oct 24, 1986
ANTI-DNA MICROASSAY
K863717
Diamedix Corp.
Immunology · 31d
Cleared Aug 15, 1986
CAPPEL DIAGNOSTICS ANA KIT
K862821
Cappel Diagnostics, Inc.
Immunology · 21d
Cleared Feb 26, 1986
AFT-HEP SYSTEM
K860183
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Dec 16, 1985
FANA 60
K854314
American Bio-Reagents, Inc.
Immunology · 49d
Cleared Jun 21, 1985
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
K852033
Meloy Laboratories, Inc.
Immunology · 43d
Cleared May 15, 1985
ANTINUCLEAR ANTIBODY TEST KIT
K851369
Modern Diagnostics, Inc.
Immunology · 40d
Cleared Mar 14, 1985
AUTOFLUOR V SYSTEM
K842991
Tech America Diagnostics
Immunology · 227d
Cleared Jan 04, 1985
MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
K844678
Meloy Laboratories, Inc.
Immunology · 35d
Cleared Nov 01, 1984
AUTOFLOUR III SYSTEM
K841984
Tech America Diagnostics
Immunology · 170d
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 Jun 22, 1984
ADP ANA IFA TEST
K842183
Apple Diagnostic Products
Immunology · 21d
Cleared Apr 25, 1984
VIRGO REAGENTS INDIRECT FLUORSCENT
K841127
Electro-Nucleonics Laboratories, Inc.
Immunology · 40d
Cleared Apr 04, 1984
ANA APPLELISA
K834241
Apple Diagnostic Products
Immunology · 120d
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 Jul 28, 1983
DNA FLOR
K831408
Medastat Scientific Corp.
Immunology · 87d
Cleared Apr 27, 1983
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
K831054
Immuno-Products Industries
Immunology · 26d