| EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay (K182353) | Phadia AB | 2018-11-27 |
| ImmuLisa Enhanced Centromere Antibody ELISA (K151559) | Immco Diagnostics, Inc. | 2016-03-11 |
| ELIA SCL-70S IMMUNOASSAY (K140493) | Phadia GmbH | 2014-10-30 |
| QUANTA FLASH CENTROMERE (K123880) | Inova Diagnostics, Inc. | 2014-02-07 |
| GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT (K131330) | Gold Standard Diagnostics | 2014-01-28 |
| ANA SCREEN ELISA (IGG) (K131185) | Euroimmun US | 2013-07-15 |
| VARELISA RECOMBI ANA SCREEN, MODEL 12 596 (K083188) | Phadia US, Inc. | 2009-03-13 |
| VARELISA RECOMBI CTD SCREEN, MODEL 13096 (K050967) | Sweden Diagnostics (Germany) GmbH | 2005-06-28 |
| VARELISA RECOMBI ANA PROFILE, MODEL 18496 (K050625) | Sweden Diagnostics (Germany) GmbH | 2005-04-26 |
| IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (K041102) | Immco Diagnostics, Inc. | 2004-10-26 |
| AESKULISA ANA HEP-2 (K040953) | Aesku, Inc. | 2004-06-23 |
| VARELISA HISTONE ANTIBODIES, MODEL 16496 (K040810) | Pharmacia Deutschland GmbH | 2004-05-14 |
| EL-ANA PROFILES: ANTI-CHROMATIN (K040291) | Theratest Laboratories, Inc. | 2004-03-11 |
| MESACUP-2 TEST CENP-B (K040200) | Rhigene, Inc. | 2004-03-04 |
| ANA DETECT (K030929) | Orgentec Diagnostika GmbH | 2003-05-02 |
| THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (K024031) | Theratest Laboratories, Inc. | 2003-02-06 |
| RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (K022018) | Rhigene, Inc. | 2002-07-05 |
| ANA EIA DIAGNOSTIC TEST KIT (K004019) | The Binding Site, Ltd. | 2001-02-15 |
| QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA (K003959) | Inova Diagnostics, Inc. | 2001-01-22 |
| EL-ANA PROFILES-2K1 (K002559) | Theratest Laboratories, Inc. | 2000-09-12 |
| THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K000879) | Zeus Scientific, Inc. | 2000-05-22 |
| THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE (K000880) | Zeus Scientific, Inc. | 2000-05-22 |
| MDI SCL-70 TEST (K000934) | Micro Detect, Inc. | 2000-04-07 |
| RHIGENE ANA ELISA TEST SYSTEM (K994071) | Rhigene, Inc. | 2000-01-18 |
| MDI SM/RNP TEST (K993635) | Micro Detect, Inc. | 2000-01-10 |
| MDI SS-A TEST (K993636) | Micro Detect, Inc. | 2000-01-10 |
| VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 (K993108) | Pharmacia & Upjohn Co. | 1999-11-12 |
| VARELISA RECOMBI ANA PROFILE (K993109) | Pharmacia & Upjohn Co. | 1999-11-12 |
| RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (K992041) | Immuno Concepts, Inc. | 1999-07-23 |
| AUTOSTAT II ANA SCREEN ELISA (K983655) | Cogent Diagnotics , Ltd. | 1999-01-28 |
| THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. (K983378) | Zeus Scientific, Inc. | 1998-11-18 |
| SERAQUEST ANTI-SSA (K980810) | Quest Intl., Inc. | 1998-05-12 |
| DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM (K980337) | Helix Diagnostics, Inc. | 1998-05-12 |
| ELIAS ANA-HEP-2 (K964385) | Elias U.S.A., Inc. | 1997-03-06 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE (K962450) | Hycor Biomedical, Inc. | 1996-11-25 |
| ORGENTEC ANTI-SM ELISA (K962062) | American Laboratory Products Co., Ltd. | 1996-11-18 |
| ORGENTEC ANTI-RNP/SM ELISA (K962057) | American Laboratory Products Co., Ltd. | 1996-11-18 |
| ORGENTEC ANTI-SCL 70 ELISA (K962055) | American Laboratory Products Co., Ltd. | 1996-11-15 |
| ORGENTEC ANTI-SS-A(RO) ELISA (K962054) | American Laboratory Products Co., Ltd. | 1996-11-15 |
| ORGENTEC ABTI-SS-BB(LA) ELISA (K962052) | American Laboratory Products Co., Ltd. | 1996-11-15 |
| ORGENTEC ANTI-JO-1 ELISA (K962053) | American Laboratory Products Co., Ltd. | 1996-11-15 |
| VARELISA ANA (4) PROFILE (K963291) | Elias U.S.A., Inc. | 1996-09-30 |
| ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY (K954814) | Orgentec | 1996-04-18 |
| ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY (K954829) | Orgentec | 1996-04-18 |
| ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY (K954815) | Orgentec | 1996-04-18 |
| ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY (K954832) | Orgentec | 1996-04-18 |
| THERATEST KIT (MODIFICATION) (K955481) | Theratest Laboratories, Inc. | 1996-03-06 |
| QUANTA LITE SSDNA (K954380) | Inova Diagnostics, Inc. | 1996-02-29 |
| IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM (K952490) | Roche Image Analysis Systems | 1995-12-15 |
| THERATEST LAB, INC., EL-ANASCR KIT (K954106) | Theratest Laboratories, Inc. | 1995-11-14 |
| THERATEST EL-ANA PROFILES TEST SYSTEM (K950716) | Theratest Laboratories, Inc. | 1995-09-26 |
| ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT (K951850) | Helix Diagnostics, Inc. | 1995-07-18 |
| ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT (K951798) | Helix Diagnostics, Inc. | 1995-07-17 |
| MARDX ENA EIA TEST SYSTEM (K946218) | Hogan & Hartson | 1995-05-15 |
| MARDX MITOCHONDRIA EIA TEST SYSTEM (K950110) | Hogan & Hartson | 1995-05-15 |
| VARELISA ANA PROFILE (K951205) | Elias U.S.A., Inc. | 1995-04-17 |
| VARELISA ANA-4 SCREEN (K951186) | Elias U.S.A., Inc. | 1995-04-17 |
| VARELISA HISTONE ANTIBODIES (K951207) | Elias U.S.A., Inc. | 1995-04-17 |
| ANTI-HISTONE ANIBODY TEST (K943585) | Immco Diagnostics, Inc. | 1995-01-20 |
| VARELISA CENTROMERE ANTIBODIES (K944171) | Elias U.S.A., Inc. | 1994-12-22 |
| VARELISA SM ANTIBODIES (K944170) | Elias U.S.A., Inc. | 1994-12-22 |
| VARELISA JO-1 ANTIBODIES (K944173) | Elias U.S.A., Inc. | 1994-12-22 |
| VARELISA RO (SS-A) ANTIBODIES (K944169) | Elias U.S.A., Inc. | 1994-12-22 |
| VARELISA SCL-70 ANTIBODIES (K944172) | Elias U.S.A., Inc. | 1994-12-22 |
| VARELISA LA (SS-B) ANTIBODIES (K944168) | Elias U.S.A., Inc. | 1994-12-22 |
| VARELISA RNP-SM ANTIBODIES (K944167) | Elias U.S.A., Inc. | 1994-12-22 |
| RADIAS ANA SCREEN ENZYME IMMUNOASSAY (K941509) | Bio-Rad | 1994-06-30 |
| AUTOZYME SCREEN (K940700) | Cambridge Life Sciences Plc. | 1994-06-10 |
| ENA SCREEN ELISA TEST SYSTEM (K941014) | Zeus Scientific, Inc. | 1994-06-10 |
| ENA PROFILE-6 ELISA TEST SYSTEM (K941409) | Zeus Scientific, Inc. | 1994-06-10 |
| HISTONE EIA TEST KIT (K940253) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| RNP EIA TEST KIT (K935415) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| RO EIA TEST KIT (K935416) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| SM EIA TEST KIT (K935414) | David A. Fuccillo, Ph.D. | 1994-05-02 |
| ELIAS ANA TOTAL (K940641) | Elias U.S.A., Inc. | 1994-03-25 |
| SYNELISA ANA TOTAL (K935468) | Elias U.S.A., Inc. | 1994-03-25 |
| AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM (K933267) | Zeus Scientific, Inc. | 1993-12-15 |
| SYNELISA ANA PROFILE (K932206) | Elias U.S.A., Inc. | 1993-12-03 |
| ANA PROFILE I (K932424) | Apotex Scientific, Inc. | 1993-08-10 |
| SYNELISA RO ABS / LA ABS (K930209) | Elias U.S.A., Inc. | 1993-06-11 |
| ACCUTEX SLE LATEX TEST (K924248) | J.S. Medical Assoc. | 1992-11-02 |
| KALESTAD ANA MICROPLATE EIA (K924087) | Bio-Rad Laboratories, Inc. | 1992-11-02 |
| DIASTAT ANTI-HISTONE KIT (K920616) | Shield Diagnostics, Ltd. | 1992-07-14 |
| HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) (K915272) | Hemagen Diagnostics, Inc. | 1992-03-17 |
| ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT (K914853) | Reads Medical Products, Inc. | 1992-01-15 |
| UBI MAGIWEL(TM) ANA QUANTITATIVE (K910033) | United Biotech, Inc. | 1991-01-25 |
| DIASTAT ENA PROFILE (K905190) | Shield Diagnostics, Ltd. | 1990-12-07 |
| ANTI-SCI-70 MICROASSAY (K902915) | Diamedix Corp. | 1990-09-06 |
| IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 (K900072) | General Biometrics, Inc. | 1990-01-24 |
| IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 (K896347) | General Biometrics, Inc. | 1989-12-05 |
| RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES (K895995) | Lipogen, Inc. | 1989-10-27 |
| RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES (K895994) | Lipogen, Inc. | 1989-10-24 |
| ANTI-SM MICROASSAY (K894894) | Diamedix Corp. | 1989-08-24 |
| MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST (K892421) | Lipogen, Inc. | 1989-05-09 |
| LA ANTIBODY TEST KIT (K874195) | Lipogen, Inc. | 1988-03-11 |
| LIPOGEN ANA TEST KIT (K875246) | Lipogen, Inc. | 1988-02-10 |
| ANTINUCLEAR ANTIBODY TEST (K872839) | Cappel Diagnostics, Inc. | 1987-10-20 |
| DS-DNA EIA DIAGNOSTIC KIT (K870453) | Biohytech International, Inc. | 1987-03-24 |
| RNP EIA DIAGNOSTIC KIT (K870457) | Biohytech International, Inc. | 1987-03-17 |
| DNP EIA DIAGNOSTIC KIT (K870456) | Biohytech International, Inc. | 1987-03-17 |