Product code DHN— Immunology
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
- Classification name
- Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Total cleared
- 110
- First cleared
- Most recent
Market context for product code DHN
FDA has cleared devices under product code DHN between 1976 and 2022, filed by 61 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2018
- 2016
- 2015
- 2014
- 2012
- 2007
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code DHN
Recent clearances under product code DHN
1–100 of 110- K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine
- K172745 — ImmuGlo HEp-2 Elite IFA
- K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
- K160265 — Image Navigator by Immuno Concepts
- K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
- K150155 — NOVA Lite DAPI ANA Kit
- K131791 — IFA 40: HEP-20-10
- K120889 — AESKUSLIDES ANA HEP-2
- K070763 — EUROIMMUN ANA IFA: HEP-20-10
- K042680 — RHIGENE HEP-ANA TEST SYSTEM
- K024220 — LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
- K024217 — LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
- K024221 — LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
- K024222 — LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
- K024224 — LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
- K024225 — LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
- K024227 — LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
- K024229 — LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
- K024230 — LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
- K024231 — LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
- K022800 — VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
- K013213 — HYPERION VISIQUANT ANA TEST KIT
- K012163 — POLYTITER SYSTEM
- K001556 — HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
- K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
- K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
- K984397 — LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
- K984398 — LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
- K984399 — LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
- K984400 — LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
- K972145 — HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
- K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
- K964165 — MICRO21 WITH NDNA
- K962276 — HEMAGEN ENA DSDNA KIT (EIA METHOD)
- K950979 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM
- K944096 — HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
- K926114 — HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
- K912292 — DIASTAT ANTI-JO-1 KIT
- K902139 — HEMAGEN ENA [JO-I] KIT
- K901596 — NOVA LITE(TM) ANA KSL
- K901595 — NOVA LITE(TM) ANA MK
- K897025 — ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
- K894659 — ANA ANTISERA CONTROL KIT
- K884400 — ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
- K880742 — NOVA LITE(TM) DSDNA
- K874873 — COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
- K872845 — BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
- K872560 — ANTI-DNP MICROASSAY
- K871801 — CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
- K871144 — TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
- K871395 — DUAL SUBSTRATE ANA
- K870458 — HISTONES EIA DIAGNOSTIC KIT
- K870732 — RAT LIVER NUCLEI TEST SYSTEM
- K863717 — ANTI-DNA MICROASSAY
- K862821 — CAPPEL DIAGNOSTICS ANA KIT
- K860183 — AFT-HEP SYSTEM
- K854314 — FANA 60
- K852033 — SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
- K851369 — ANTINUCLEAR ANTIBODY TEST KIT
- K842991 — AUTOFLUOR V SYSTEM
- K844678 — MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
- K841984 — AUTOFLOUR III SYSTEM
- K843225 — COLORZYME NDNA TEST SYSTEM
- K843347 — RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
- K841776 — ANA SENSITIVITY/SPECIFICITY CONTROL
- K842183 — ADP ANA IFA TEST
- K841127 — VIRGO REAGENTS INDIRECT FLUORSCENT
- K834241 — ANA APPLELISA
- K833119 — AUTOIMMUNE TEST 1/2/3 SYSTEM
- K832383 — IDT ANA STIQ ASSAY
- K831408 — DNA FLOR
- K831054 — ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
- K830214 — AFT SYSTEM III
- K822681 — ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
- K822682 — ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
- K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY
- K820945 — SERA FOR ANTINUCLEAR ANTIBODIES
- K822397 — ANA HEP-2 FLUORO-KIT
- K822607 — ANTINUCLEAR ANTOBODY CELL SUBSTRATE
- K820265 — ANA TEST (MOUSE LIVER SUBSTRATE)
- K813592 — QUANTAFLUOR FLUORESCENT TEST REAGENTS
- K812314 — CRITHIDNA ANTI-DNA TEST KIT
- K811714 — HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
- K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
- K811022 — ANA TEST KIT
- K810301 — CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
- K810081 — SCRIPPSERA ANA REFERENCE CONTROL SERA
- K802299 — K/K (ASMA/ANA) UNIVERSAL BIOPAK
- K803276 — ANA-IFA TEST SYSTEM
- K802527 — TEST KIT FOR DETECTION OF ANTINUCLEAR
- K801046 — ANATON
- K792184 — LAB-TEK ANA TEST KIT
- K791928 — ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
- K791995 — ANTI NUCLEAR ANTIBODY TEST
- K791493 — ANTI-NUCLEAR ANTIBODY TEST
- K790280 — AUTOANTIBODY REAGENTS, AFT SYSTEM II
- K790252 — ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
- K782048 — TEST KIT, IIF-ANA
- K782041 — FIAX TEST KIT
- K780899 — FLUORESCENT ANTI-NATIVE DNA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.