FDA Product Code
FDA Product Code DHN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 110 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K172745 | ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. | 2018-06-05 | Traditional | PDF ↗ |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | Aesku Systems GmbH&Co.Kg | 2016-07-28 | Traditional | PDF ↗ |
| K160265 | Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | 2016-06-17 | Traditional | PDF ↗ |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | Euroimmun Us, Inc. | 2015-04-17 | Traditional | PDF ↗ |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | 2015-04-08 | Traditional | PDF ↗ |
| K131791 | IFA 40: HEP-20-10 | Euroimmun US | 2014-02-26 | Traditional | PDF ↗ |
| K120889 | AESKUSLIDES ANA HEP-2 | Aesku Diagnostics | 2012-10-15 | Traditional | PDF ↗ |
| K070763 | EUROIMMUN ANA IFA: HEP-20-10 | Euroimmun Us, LLC | 2007-05-22 | Traditional | PDF ↗ |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | Corgenix, Inc. | 2004-11-19 | Traditional | PDF ↗ |
| K024220 | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | Bio-Rad | 2003-01-17 | Traditional | PDF ↗ |
| K024227 | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024229 | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024224 | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024222 | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024225 | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024217 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024221 | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024230 | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 | Bio-Rad | 2003-01-15 | Traditional | PDF ↗ |
| K024231 | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | Bio-Rad | 2003-01-13 | Traditional | PDF ↗ |
| K022800 | VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM | Hyperion, Inc. | 2002-11-25 | Traditional | PDF ↗ |
| K013213 | HYPERION VISIQUANT ANA TEST KIT | Hyperion, Inc. | 2002-06-04 | Traditional | PDF ↗ |
| K012163 | POLYTITER SYSTEM | Polymedco, Inc. | 2001-08-20 | Traditional | PDF ↗ |
| K001556 | HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY | The Binding Site, Ltd. | 2000-08-21 | Traditional | PDF ↗ |
| K990915 | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | Stellar Bio Systems, Inc. | 1999-04-21 | Traditional | PDF ↗ |
| K984400 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 | Bio-Rad | 1998-12-18 | Traditional | PDF ↗ |
| K984398 | LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 | Bio-Rad | 1998-12-18 | Traditional | PDF ↗ |
| K984397 | LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 | Bio-Rad | 1998-12-18 | Traditional | PDF ↗ |
| K983924 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | Immuno Concepts, Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K984399 | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 | Bio-Rad | 1998-12-18 | Traditional | PDF ↗ |
| K972145 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | Immuno Concepts, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K970198 | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES | Scimedx Corp. | 1997-02-20 | Traditional | PDF ↗ |
| K964165 | MICRO21 WITH NDNA | Triangle Biomedical Sciences, Inc. | 1997-01-03 | Traditional | PDF ↗ |
| K962276 | HEMAGEN ENA DSDNA KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1996-12-05 | Traditional | PDF ↗ |
| K950979 | HEP-2000 COLORZYME ANA-RO TEST SYSTEM | Immuno Concepts, Inc. | 1995-06-01 | Traditional | PDF ↗ |
| K944096 | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | Immuno Concepts, Inc. | 1994-11-21 | Traditional | PDF ↗ |
| K926114 | HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM | Tissue Culture Biotec, Inc. | 1993-05-20 | Traditional | PDF ↗ |
| K912292 | DIASTAT ANTI-JO-1 KIT | Shield Diagnostics, Ltd. | 1991-07-30 | Traditional | PDF ↗ |
| K902139 | HEMAGEN ENA [JO-I] KIT | Hemagen Diagnostics, Inc. | 1990-05-18 | Traditional | PDF ↗ |
| K901596 | NOVA LITE(TM) ANA KSL | Inova Diagnostics, Inc. | 1990-05-02 | Traditional | PDF ↗ |
| K901595 | NOVA LITE(TM) ANA MK | Inova Diagnostics, Inc. | 1990-04-26 | Traditional | PDF ↗ |
| K897025 | ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM | Zeus Scientific, Inc. | 1990-01-02 | Traditional | PDF ↗ |
| K894659 | ANA ANTISERA CONTROL KIT | Lipogen, Inc. | 1989-09-21 | Traditional | PDF ↗ |
| K884400 | ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) | Immco Diagnostics, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K880742 | NOVA LITE(TM) DSDNA | Inova Diagnostics, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K874873 | COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 | Diagnostic Products Corp. | 1988-02-10 | Traditional | PDF ↗ |
| K872845 | BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM | Bion Ent., Ltd. | 1987-08-17 | Traditional | PDF ↗ |
| K872560 | ANTI-DNP MICROASSAY | Diamedix Corp. | 1987-07-21 | Traditional | PDF ↗ |
| K871801 | CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT | Cytotech, Inc. | 1987-06-09 | Traditional | PDF ↗ |
| K871144 | TANGENT SYSTEM(TM) ANA PROFILE TEST KIT | Vitrotec Laboratories, Inc. | 1987-04-29 | Traditional | PDF ↗ |
| K871395 | DUAL SUBSTRATE ANA | Val Tech Diagnostics, Inc. | 1987-04-20 | Traditional | PDF ↗ |
| K870458 | HISTONES EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870732 | RAT LIVER NUCLEI TEST SYSTEM | Val Tech Diagnostics, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K863717 | ANTI-DNA MICROASSAY | Diamedix Corp. | 1986-10-24 | Traditional | PDF ↗ |
| K862821 | CAPPEL DIAGNOSTICS ANA KIT | Cappel Diagnostics, Inc. | 1986-08-15 | Traditional | PDF ↗ |
| K860183 | AFT-HEP SYSTEM | Behring Diagnostics, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K854314 | FANA 60 | American Bio-Reagents, Inc. | 1985-12-16 | Traditional | PDF ↗ |
| K852033 | SS-A(RO) & SS-B(LA) ANTIBODY ASSAY | Meloy Laboratories, Inc. | 1985-06-21 | Traditional | PDF ↗ |
| K851369 | ANTINUCLEAR ANTIBODY TEST KIT | Modern Diagnostics, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K842991 | AUTOFLUOR V SYSTEM | Tech America Diagnostics | 1985-03-14 | Traditional | PDF ↗ |
| K844678 | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL | Meloy Laboratories, Inc. | 1985-01-04 | Traditional | PDF ↗ |
| K843225 | COLORZYME NDNA TEST SYSTEM | Immuno Concepts, Inc. | 1984-11-01 | Traditional | PDF ↗ |
| K841984 | AUTOFLOUR III SYSTEM | Tech America Diagnostics | 1984-11-01 | Traditional | PDF ↗ |
| K843347 | RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON | E.I. Dupont DE Nemours & Co., Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K842183 | ADP ANA IFA TEST | Apple Diagnostic Products | 1984-06-22 | Traditional | PDF ↗ |
| K841776 | ANA SENSITIVITY/SPECIFICITY CONTROL | Behring Diagnostics, Inc. | 1984-06-22 | Traditional | PDF ↗ |
| K841127 | VIRGO REAGENTS INDIRECT FLUORSCENT | Electro-Nucleonics Laboratories, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K834241 | ANA APPLELISA | Apple Diagnostic Products | 1984-04-04 | Traditional | PDF ↗ |
| K833119 | AUTOIMMUNE TEST 1/2/3 SYSTEM | Atlantic Antibodies | 1983-11-21 | Traditional | PDF ↗ |
| K832383 | IDT ANA STIQ ASSAY | Intl. Diagnostic Technology | 1983-08-31 | Traditional | PDF ↗ |
| K831408 | DNA FLOR | Medastat Scientific Corp. | 1983-07-28 | Traditional | PDF ↗ |
| K831054 | ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB | Immuno-Products Industries | 1983-04-27 | Traditional | PDF ↗ |
| K830214 | AFT SYSTEM III | Calbiochem-Behring Corp. | 1983-03-09 | Traditional | PDF ↗ |
| K822681 | ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) | Amico Lab, Inc. | 1982-12-13 | Traditional | PDF ↗ |
| K822682 | ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K | Amico Lab, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K823055 | FLOUROSET IMMUNOFLUORESCENT ANTIBODY | Immulok, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K820945 | SERA FOR ANTINUCLEAR ANTIBODIES | Centers for Disease Control and Prevention | 1982-10-26 | Traditional | PDF ↗ |
| K822397 | ANA HEP-2 FLUORO-KIT | Clinical Sciences, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822607 | ANTINUCLEAR ANTOBODY CELL SUBSTRATE | Immulok, Inc. | 1982-09-17 | Traditional | PDF ↗ |
| K820265 | ANA TEST (MOUSE LIVER SUBSTRATE) | Meloy Laboratories, Inc. | 1982-02-12 | Traditional | PDF ↗ |
| K813592 | QUANTAFLUOR FLUORESCENT TEST REAGENTS | Kallestad Laboratories, Inc. | 1982-01-18 | Traditional | PDF ↗ |
| K812314 | CRITHIDNA ANTI-DNA TEST KIT | Antibodies, Inc. | 1981-09-01 | Traditional | PDF ↗ |
| K811714 | HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT | Scripps-Miles, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K810985 | ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT | Immuno-Products Industries | 1981-05-01 | Traditional | PDF ↗ |
| K811022 | ANA TEST KIT | Immuno-Diagnostic Products, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810301 | CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST | Immuno Concepts, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810081 | SCRIPPSERA ANA REFERENCE CONTROL SERA | Scripps-Miles, Inc. | 1981-02-09 | Traditional | PDF ↗ |
| K802299 | K/K (ASMA/ANA) UNIVERSAL BIOPAK | Bioware Products | 1981-01-29 | Traditional | PDF ↗ |
| K803276 | ANA-IFA TEST SYSTEM | Immuno Concepts, Inc. | 1981-01-26 | Traditional | PDF ↗ |
| K802527 | TEST KIT FOR DETECTION OF ANTINUCLEAR | Bartels & Stout, Inc. | 1981-01-05 | Traditional | PDF ↗ |
| K801046 | ANATON | Armkel, LLC | 1980-05-14 | Traditional | PDF ↗ |
| K792184 | LAB-TEK ANA TEST KIT | Miles Laboratories, Inc. | 1979-11-30 | Traditional | PDF ↗ |
| K791928 | ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT | Keith E. Abbott | 1979-11-13 | Traditional | PDF ↗ |
| K791995 | ANTI NUCLEAR ANTIBODY TEST | Meda Stat Diagnostics, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K791493 | ANTI-NUCLEAR ANTIBODY TEST | Meloy Laboratories, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K790280 | AUTOANTIBODY REAGENTS, AFT SYSTEM II | Calbiochem-Behring Corp. | 1979-04-23 | Traditional | PDF ↗ |
| K790252 | ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI | Meloy Laboratories, Inc. | 1979-03-15 | Traditional | PDF ↗ |
| K782048 | TEST KIT, IIF-ANA | Medica Corp. | 1979-01-17 | Traditional | PDF ↗ |
| K782041 | FIAX TEST KIT | Idt, A Division of Whittaker M.A. Bioproducts | 1979-01-03 | Traditional | PDF ↗ |
| K780899 | FLUORESCENT ANTI-NATIVE DNA TEST | Kallestad Laboratories, Inc. | 1978-09-07 | Traditional | PDF ↗ |
Product code DHN · Class II · Immunology. Data: openFDA.