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