Product code LJM
- Device name
- Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5100
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | Phadia AB | 2018-11-27 |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Immco Diagnostics, Inc. | 2016-03-11 |
| K140493 | ELIA SCL-70S IMMUNOASSAY | Phadia GmbH | 2014-10-30 |
| K123880 | QUANTA FLASH CENTROMERE | Inova Diagnostics, Inc. | 2014-02-07 |
| K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | Gold Standard Diagnostics | 2014-01-28 |
| K131185 | ANA SCREEN ELISA (IGG) | Euroimmun US | 2013-07-15 |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | Phadia US, Inc. | 2009-03-13 |
| K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | Sweden Diagnostics (Germany) GmbH | 2005-06-28 |
| K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | Sweden Diagnostics (Germany) GmbH | 2005-04-26 |
| K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | Immco Diagnostics, Inc. | 2004-10-26 |
| K040953 | AESKULISA ANA HEP-2 | Aesku, Inc. | 2004-06-23 |
| K040810 | VARELISA HISTONE ANTIBODIES, MODEL 16496 | Pharmacia Deutschland GmbH | 2004-05-14 |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | Theratest Laboratories, Inc. | 2004-03-11 |
| K040200 | MESACUP-2 TEST CENP-B | Rhigene, Inc. | 2004-03-04 |
| K030929 | ANA DETECT | Orgentec Diagnostika GmbH | 2003-05-02 |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | Theratest Laboratories, Inc. | 2003-02-06 |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | Rhigene, Inc. | 2002-07-05 |
| K004019 | ANA EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 2001-02-15 |
| K003959 | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA | Inova Diagnostics, Inc. | 2001-01-22 |
| K002559 | EL-ANA PROFILES-2K1 | Theratest Laboratories, Inc. | 2000-09-12 |
| 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 |
| 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 |
| K000934 | MDI SCL-70 TEST | Micro Detect, Inc. | 2000-04-07 |
| K994071 | RHIGENE ANA ELISA TEST SYSTEM | Rhigene, Inc. | 2000-01-18 |
| K993636 | MDI SS-A TEST | Micro Detect, Inc. | 2000-01-10 |
| K993635 | MDI SM/RNP TEST | Micro Detect, Inc. | 2000-01-10 |
| K993109 | VARELISA RECOMBI ANA PROFILE | Pharmacia & Upjohn Co. | 1999-11-12 |
| K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 | Pharmacia & Upjohn Co. | 1999-11-12 |
| K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 | Immuno Concepts, Inc. | 1999-07-23 |
| K983655 | AUTOSTAT II ANA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1999-01-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850054026569 | QMedix™ | Diagnostic Automation, Inc. | 2024-04-23 |
| 00840239035769 | Anti-SS-B ELISA | DRG International Inc | 2023-10-09 |
| 04048474041170 | ANA Detect ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474027839 | SSB (La) IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474027822 | SSA (Ro) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474027808 | ENA-6-Profile ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474027792 | ENA Screen (entractable nuclear antigen) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474027747 | DNA (ds) IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002939 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 04049016084785 | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016124917 | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016124900 | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016083139 | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 00845714004353 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-24 |
| 07333066014579 | EliA Scl-70 Well | Phadia AB | 2016-09-23 |
| 07333066014586 | EliA Jo-1 Well | Phadia AB | 2016-09-23 |
| 07333066014845 | EliA Scl-70S Well | Phadia AB | 2016-09-23 |
| 00845714002793 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-09-23 |
| 00847865012331 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002721 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002448 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865001342 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000093 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000086 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950544128 | QUANTA Lite® Centromere ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593744 | QUANTA Lite® ssDNA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595632 | QUANTA Flash® Centromere Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |