FDA Product Code DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Leading manufacturers include Bio-Rad, Immco Diagnostics, Inc. and Zeus Scientific, Inc..
110
Total
110
Cleared
67d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DHN)
110 devices
Cleared
Apr 29, 2022
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
Zeus Scientific, Inc.
Immunology
654d
Cleared
Jun 05, 2018
ImmuGlo HEp-2 Elite IFA
Immco Diagnostics, Inc.
Immunology
266d
Cleared
Jan 17, 2003
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
Bio-Rad
Immunology
25d
Cleared
Jan 15, 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
Bio-Rad
Immunology
23d
Cleared
Jan 15, 2003
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
Bio-Rad
Immunology
23d
Cleared
Jan 13, 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
Bio-Rad
Immunology
21d
Cleared
Dec 18, 1998
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
Bio-Rad
Immunology
9d
Cleared
Dec 18, 1998
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
Bio-Rad
Immunology
9d
Cleared
Dec 18, 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
Bio-Rad
Immunology
9d
Cleared
Dec 18, 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
Bio-Rad
Immunology
9d
Cleared
Feb 10, 1988
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
Diagnostic Products Corp.
Immunology
72d
Cleared
Oct 05, 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
E.I. Dupont DE Nemours & Co., Inc.
Immunology
39d
About Product Code DHN - Regulatory Context
510(k) Submission Activity
110 total 510(k) submissions under product code DHN since 1976, with 110 receiving FDA clearance (average review time: 67 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.