| EliA Ro52, EliA Ro60 (K210902) | Phadia AB | 2022-07-27 |
| ANA-SCREEN WITH MDSS (K113610) | Bio-Rad Laboratories | 2012-07-09 |
| ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY (K082759) | Phadia US, Inc. | 2009-04-10 |
| AESKULISA ANA HEP-2, REF 30-7115US (K081104) | Aesku Diagnostics | 2008-05-02 |
| BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 (K041658) | Bio-Rad Laboratories, Inc. | 2004-12-20 |
| ATHENA MULTI-LYTE ANA-II TEST SYSTEM (K042416) | Zeus Scientific, Inc. | 2004-10-08 |
| REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 (K034013) | Corgenix, Inc. | 2004-01-08 |
| AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM (K030775) | Immuno Concepts, N.A. , Ltd. | 2003-05-12 |
| LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (K024218) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (K024232) | Bio-Rad | 2003-01-17 |
| LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 (K024223) | Bio-Rad | 2003-01-13 |
| LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 (K024226) | Bio-Rad | 2003-01-10 |
| ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (K021257) | Diagnostic Products Corp. | 2002-06-03 |
| MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM (K021103) | Zeus Scientific, Inc. | 2002-04-24 |
| ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM (K011244) | Zeus Scientific, Inc. | 2001-12-10 |
| DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM (K993294) | Diamedix Corp. | 1999-10-25 |
| LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 (K984473) | Bio-Rad | 1998-12-22 |
| LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 (K984470) | Bio-Rad | 1998-12-22 |
| LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 (K984478) | Bio-Rad | 1998-12-22 |
| LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 (K984464) | Bio-Rad | 1998-12-22 |
| LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 (K984475) | Bio-Rad | 1998-12-22 |
| QUALITROL ANA CONTROL SERUM SET (K961815) | Consolidated Technologies, Inc. | 1996-09-27 |
| HYTEC AUTOIMMUNE KIT (SS-A) (K954392) | Hycor Biomedical, Inc. | 1995-12-26 |
| HYTEC AUTOIMMUNE KITS (SS-B) (K954891) | Hycor Biomedical, Inc. | 1995-12-26 |
| ENZYME IMMUNOASSAY ANA SCREENING TEST KIT (K954723) | Helix Diagnostics, Inc. | 1995-12-15 |
| ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT (K954700) | Helix Diagnostics, Inc. | 1995-12-15 |
| DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT (K932876) | Shield Diagnostics, Ltd. | 1993-11-15 |
| SYNELISA CENP-B ANTIBODIES (K931255) | Elias U.S.A., Inc. | 1993-09-24 |
| RHEUMELISA II HISTONE ANTIBODY TEST KIT (K932679) | Biowhittaker Molecular Applications, Inc. | 1993-08-23 |
| SYLNELISA HISTONE ANTIBODIES (K932302) | Elias U.S.A., Inc. | 1993-08-23 |
| SYN ELISA DSDNA ANTIBODIES (K921132) | Elias U.S.A., Inc. | 1992-12-01 |
| THE THERATEST EL-ANA PROFILES (K914454) | Theratest Laboratories, Inc. | 1992-05-22 |
| AUTOSTAT(TM) ANTI-DSNA (K913342) | Cogent Diagnotics , Ltd. | 1992-05-01 |
| ENCORE SCL-70 (K920150) | Clark Laboratories, Inc. | 1992-03-18 |
| ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM (K914550) | Diagnostic Resources, Inc. | 1992-02-11 |
| DISTAT ANTI-SCL-70 KIT (K912291) | Shield Diagnostics, Ltd. | 1991-07-30 |
| SERATEST ENA [SCL-70] KIT (K894411) | Hemagen Diagnostics, Inc. | 1989-08-02 |
| QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA (K893896) | Biostar Medical Products, Inc. | 1989-07-14 |
| SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM (K893897) | Biostar Medical Products, Inc. | 1989-06-23 |
| ANA-5 AUTOANTIBODY PROFILE KIT (K885224) | Autoimmunity Diagnostics Corp. | 1989-04-14 |
| ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) (K883949) | Immco Diagnostics, Inc. | 1988-10-27 |
| ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) (K883883) | Immco Diagnostics, Inc. | 1988-10-27 |
| ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY (K882740) | Lipogen, Inc. | 1988-09-22 |
| NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) (K874115) | Sigma Diagnostics, Inc. | 1987-11-04 |
| ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS (K873249) | Cytotech, Inc. | 1987-09-22 |
| ANA TEST KIT (K864668) | Val Tech Diagnostics, Inc. | 1987-03-12 |
| KALLESTAD SM/RNP TEST REAGENT (K862313) | Kallestad Laboratories, Inc. | 1986-08-06 |
| SERATEST DNA DETERMINATION (K842563) | Seragen Diagnostics, Inc. | 1984-10-25 |
| LEAP LE TEST KIT (K842484) | Cooper Biomedical, Inc. | 1984-07-11 |
| ANA-CHECK (K831463) | Diagnostic Technology, Inc. | 1983-06-08 |