FDA Product Code
FDA Product Code LJM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 112 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | Phadia AB | 2018-11-27 | Traditional | PDF ↗ |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Immco Diagnostics, Inc. | 2016-03-11 | Traditional | PDF ↗ |
| K140493 | ELIA SCL-70S IMMUNOASSAY | Phadia GmbH | 2014-10-30 | Traditional | PDF ↗ |
| K123880 | QUANTA FLASH CENTROMERE | Inova Diagnostics, Inc. | 2014-02-07 | Traditional | PDF ↗ |
| K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | Gold Standard Diagnostics | 2014-01-28 | Traditional | PDF ↗ |
| K131185 | ANA SCREEN ELISA (IGG) | Euroimmun US | 2013-07-15 | Traditional | PDF ↗ |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | Phadia US, Inc. | 2009-03-13 | Traditional | PDF ↗ |
| K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | Sweden Diagnostics (Germany) GmbH | 2005-06-28 | Traditional | PDF ↗ |
| K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | Sweden Diagnostics (Germany) GmbH | 2005-04-26 | Traditional | PDF ↗ |
| K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | Immco Diagnostics, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K040953 | AESKULISA ANA HEP-2 | Aesku, Inc. | 2004-06-23 | Traditional | PDF ↗ |
| K040810 | VARELISA HISTONE ANTIBODIES, MODEL 16496 | Pharmacia Deutschland GmbH | 2004-05-14 | Traditional | PDF ↗ |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | Theratest Laboratories, Inc. | 2004-03-11 | Traditional | PDF ↗ |
| K040200 | MESACUP-2 TEST CENP-B | Rhigene, Inc. | 2004-03-04 | Traditional | PDF ↗ |
| K030929 | ANA DETECT | Orgentec Diagnostika GmbH | 2003-05-02 | Traditional | PDF ↗ |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | Theratest Laboratories, Inc. | 2003-02-06 | Traditional | PDF ↗ |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | Rhigene, Inc. | 2002-07-05 | Special | PDF ↗ |
| K004019 | ANA EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 2001-02-15 | Traditional | PDF ↗ |
| K003959 | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA | Inova Diagnostics, Inc. | 2001-01-22 | Traditional | PDF ↗ |
| K002559 | EL-ANA PROFILES-2K1 | Theratest Laboratories, Inc. | 2000-09-12 | Traditional | PDF ↗ |
| K000879 | THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 2000-05-22 | Traditional | PDF ↗ |
| K000880 | THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 2000-05-22 | Traditional | PDF ↗ |
| K000934 | MDI SCL-70 TEST | Micro Detect, Inc. | 2000-04-07 | Traditional | PDF ↗ |
| K994071 | RHIGENE ANA ELISA TEST SYSTEM | Rhigene, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K993636 | MDI SS-A TEST | Micro Detect, Inc. | 2000-01-10 | Traditional | PDF ↗ |
| K993635 | MDI SM/RNP TEST | Micro Detect, Inc. | 2000-01-10 | Traditional | PDF ↗ |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | Pharmacia & Upjohn Co. | 1999-11-12 | Traditional | PDF ↗ |
| K993109 | VARELISA RECOMBI ANA PROFILE | Pharmacia & Upjohn Co. | 1999-11-12 | Traditional | PDF ↗ |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | Immuno Concepts, Inc. | 1999-07-23 | Traditional | PDF ↗ |
| K983655 | AUTOSTAT II ANA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1999-01-28 | Traditional | PDF ↗ |
| K983378 | THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. | Zeus Scientific, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K980810 | SERAQUEST ANTI-SSA | Quest Intl., Inc. | 1998-05-12 | Traditional | PDF ↗ |
| K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | Helix Diagnostics, Inc. | 1998-05-12 | Traditional | PDF ↗ |
| K964385 | ELIAS ANA-HEP-2 | Elias U.S.A., Inc. | 1997-03-06 | Traditional | PDF ↗ |
| K962450 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE | Hycor Biomedical, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K962057 | ORGENTEC ANTI-RNP/SM ELISA | American Laboratory Products Co., Ltd. | 1996-11-18 | Traditional | PDF ↗ |
| K962062 | ORGENTEC ANTI-SM ELISA | American Laboratory Products Co., Ltd. | 1996-11-18 | Traditional | PDF ↗ |
| K962054 | ORGENTEC ANTI-SS-A(RO) ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | Traditional | PDF ↗ |
| K962055 | ORGENTEC ANTI-SCL 70 ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | Traditional | PDF ↗ |
| K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | Traditional | PDF ↗ |
| K962053 | ORGENTEC ANTI-JO-1 ELISA | American Laboratory Products Co., Ltd. | 1996-11-15 | Traditional | PDF ↗ |
| K963291 | VARELISA ANA (4) PROFILE | Elias U.S.A., Inc. | 1996-09-30 | Traditional | PDF ↗ |
| K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | Traditional | PDF ↗ |
| K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | Traditional | PDF ↗ |
| K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | Traditional | PDF ↗ |
| K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY | Orgentec | 1996-04-18 | Traditional | PDF ↗ |
| K955481 | THERATEST KIT (MODIFICATION) | Theratest Laboratories, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K954380 | QUANTA LITE SSDNA | Inova Diagnostics, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K952490 | IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM | Roche Image Analysis Systems | 1995-12-15 | Traditional | PDF ↗ |
| K954106 | THERATEST LAB, INC., EL-ANASCR KIT | Theratest Laboratories, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K950716 | THERATEST EL-ANA PROFILES TEST SYSTEM | Theratest Laboratories, Inc. | 1995-09-26 | Traditional | PDF ↗ |
| K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1995-07-18 | Traditional | PDF ↗ |
| K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K946218 | MARDX ENA EIA TEST SYSTEM | Hogan & Hartson | 1995-05-15 | Traditional | PDF ↗ |
| K950110 | MARDX MITOCHONDRIA EIA TEST SYSTEM | Hogan & Hartson | 1995-05-15 | Traditional | PDF ↗ |
| K951186 | VARELISA ANA-4 SCREEN | Elias U.S.A., Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K951207 | VARELISA HISTONE ANTIBODIES | Elias U.S.A., Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K951205 | VARELISA ANA PROFILE | Elias U.S.A., Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K943585 | ANTI-HISTONE ANIBODY TEST | Immco Diagnostics, Inc. | 1995-01-20 | Traditional | PDF ↗ |
| K944171 | VARELISA CENTROMERE ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944172 | VARELISA SCL-70 ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944167 | VARELISA RNP-SM ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944173 | VARELISA JO-1 ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944170 | VARELISA SM ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944169 | VARELISA RO (SS-A) ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944168 | VARELISA LA (SS-B) ANTIBODIES | Elias U.S.A., Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K941509 | RADIAS ANA SCREEN ENZYME IMMUNOASSAY | Bio-Rad | 1994-06-30 | Traditional | PDF ↗ |
| K940700 | AUTOZYME SCREEN | Cambridge Life Sciences Plc. | 1994-06-10 | Traditional | PDF ↗ |
| K941014 | ENA SCREEN ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K941409 | ENA PROFILE-6 ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K940253 | HISTONE EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | Traditional | PDF ↗ |
| K935414 | SM EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | Traditional | PDF ↗ |
| K935416 | RO EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | Traditional | PDF ↗ |
| K935415 | RNP EIA TEST KIT | David A. Fuccillo, Ph.D. | 1994-05-02 | Traditional | PDF ↗ |
| K940641 | ELIAS ANA TOTAL | Elias U.S.A., Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K935468 | SYNELISA ANA TOTAL | Elias U.S.A., Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K933267 | AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K932206 | SYNELISA ANA PROFILE | Elias U.S.A., Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K932424 | ANA PROFILE I | Apotex Scientific, Inc. | 1993-08-10 | Traditional | PDF ↗ |
| K930209 | SYNELISA RO ABS / LA ABS | Elias U.S.A., Inc. | 1993-06-11 | Traditional | PDF ↗ |
| K924248 | ACCUTEX SLE LATEX TEST | J.S. Medical Assoc. | 1992-11-02 | Traditional | PDF ↗ |
| K924087 | KALESTAD ANA MICROPLATE EIA | Bio-Rad Laboratories, Inc. | 1992-11-02 | Traditional | PDF ↗ |
| K920616 | DIASTAT ANTI-HISTONE KIT | Shield Diagnostics, Ltd. | 1992-07-14 | Traditional | PDF ↗ |
| K915272 | HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1992-03-17 | Traditional | PDF ↗ |
| K914853 | ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT | Reads Medical Products, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K910033 | UBI MAGIWEL(TM) ANA QUANTITATIVE | United Biotech, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K905190 | DIASTAT ENA PROFILE | Shield Diagnostics, Ltd. | 1990-12-07 | Traditional | PDF ↗ |
| K902915 | ANTI-SCI-70 MICROASSAY | Diamedix Corp. | 1990-09-06 | Traditional | PDF ↗ |
| K900072 | IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 | General Biometrics, Inc. | 1990-01-24 | Traditional | PDF ↗ |
| K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 | General Biometrics, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K895995 | RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES | Lipogen, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K895994 | RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES | Lipogen, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K894894 | ANTI-SM MICROASSAY | Diamedix Corp. | 1989-08-24 | Traditional | PDF ↗ |
| K892421 | MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST | Lipogen, Inc. | 1989-05-09 | Traditional | PDF ↗ |
| K874195 | LA ANTIBODY TEST KIT | Lipogen, Inc. | 1988-03-11 | Traditional | PDF ↗ |
| K875246 | LIPOGEN ANA TEST KIT | Lipogen, Inc. | 1988-02-10 | Traditional | PDF ↗ |
| K872839 | ANTINUCLEAR ANTIBODY TEST | Cappel Diagnostics, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K870453 | DS-DNA EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K870452 | SS-DNA EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870456 | DNP EIA DIAGNOSTIC KIT | Biohytech International, Inc. | 1987-03-17 | Traditional | PDF ↗ |
Product code LJM · Class II · Immunology. Data: openFDA.