Panels › Immunology › Product code LJM · Class 2
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Regulation 866.5100
0510(k)s in 12 months (112 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LJM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 2018 | K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay Phadia AB, SE | LJM |
| Mar 11, 2016 | K151559 | ImmuLisa Enhanced Centromere Antibody ELISA Immco Diagnostics, Inc. | LJM |
| Oct 30, 2014 | K140493 | ELIA SCL-70S IMMUNOASSAY Phadia GmbH | LJM |
| Feb 7, 2014 | K123880 | QUANTA FLASH CENTROMERE Inova Diagnostics, Inc. | LJM |
| Jan 28, 2014 | K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT Gold Standard Diagnostics | LJM |
| Jul 15, 2013 | K131185 | ANA SCREEN ELISA (IGG) Euroimmun US | LJM |
| Mar 13, 2009 | K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 Phadia US, Inc. | LJM |
| Jun 28, 2005 | K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 Sweden Diagnostics (Germany) GmbH, DE | LJM |
| Apr 26, 2005 | K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 Sweden Diagnostics (Germany) GmbH, DE | LJM |
| Oct 26, 2004 | K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA Immco Diagnostics, Inc. | LJM |
| Jun 23, 2004 | K040953 | AESKULISA ANA HEP-2 Aesku, Inc. | LJM |
| May 14, 2004 | K040810 | VARELISA HISTONE ANTIBODIES, MODEL 16496 Pharmacia Deutschland GmbH, DE | LJM |
| Mar 11, 2004 | K040291 | EL-ANA PROFILES: ANTI-CHROMATIN Theratest Laboratories, Inc. | LJM |
| Mar 4, 2004 | K040200 | MESACUP-2 TEST CENP-B Rhigene, Inc. | LJM |
| May 2, 2003 | K030929 | ANA DETECT Orgentec Diagnostika GmbH | LJM |
| Feb 6, 2003 | K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE Theratest Laboratories, Inc. | LJM |
| Jul 5, 2002 | K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 Rhigene, Inc. | LJM |
| Feb 15, 2001 | K004019 | ANA EIA DIAGNOSTIC TEST KIT The Binding Site, Ltd. | LJM |
| Jan 22, 2001 | K003959 | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA Inova Diagnostics, Inc. | LJM |
| Sep 12, 2000 | K002559 | EL-ANA PROFILES-2K1 Theratest Laboratories, Inc. | LJM |
| May 22, 2000 | K000880 | THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LJM |
| May 22, 2000 | K000879 | THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LJM |
| Apr 7, 2000 | K000934 | MDI SCL-70 TEST Micro Detect, Inc. | LJM |
| Jan 18, 2000 | K994071 | RHIGENE ANA ELISA TEST SYSTEM Rhigene, Inc. | LJM |
| Jan 10, 2000 | K993636 | MDI SS-A TEST Micro Detect, Inc. | LJM |
| Jan 10, 2000 | K993635 | MDI SM/RNP TEST Micro Detect, Inc. | LJM |
| Nov 12, 1999 | K993109 | VARELISA RECOMBI ANA PROFILE Pharmacia & Upjohn Co. | LJM |
| Nov 12, 1999 | K993108 | VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 Pharmacia & Upjohn Co. | LJM |
| Jul 23, 1999 | K992041 | RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 Immuno Concepts, Inc. | LJM |
| Jan 28, 1999 | K983655 | AUTOSTAT II ANA SCREEN ELISA Cogent Diagnotics , Ltd., GB | LJM |
| Nov 18, 1998 | K983378 | THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. Zeus Scientific, Inc. | LJM |
| May 12, 1998 | K980810 | SERAQUEST ANTI-SSA Quest Intl., Inc. | LJM |
| May 12, 1998 | K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM Helix Diagnostics, Inc. | LJM |
| Mar 6, 1997 | K964385 | ELIAS ANA-HEP-2 Elias U.S.A., Inc. | LJM |
| Nov 25, 1996 | K962450 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE Hycor Biomedical, Inc. | LJM |
| Nov 18, 1996 | K962062 | ORGENTEC ANTI-SM ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 18, 1996 | K962057 | ORGENTEC ANTI-RNP/SM ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962055 | ORGENTEC ANTI-SCL 70 ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962054 | ORGENTEC ANTI-SS-A(RO) ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962053 | ORGENTEC ANTI-JO-1 ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA American Laboratory Products Co., Ltd. | LJM |
| Sep 30, 1996 | K963291 | VARELISA ANA (4) PROFILE Elias U.S.A., Inc. | LJM |
| Apr 18, 1996 | K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY Orgentec | LJM |
| Apr 18, 1996 | K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY Orgentec | LJM |
| Apr 18, 1996 | K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY Orgentec | LJM |
| Apr 18, 1996 | K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY Orgentec | LJM |
| Mar 6, 1996 | K955481 | THERATEST KIT (MODIFICATION) Theratest Laboratories, Inc. | LJM |
| Feb 29, 1996 | K954380 | QUANTA LITE SSDNA Inova Diagnostics, Inc. | LJM |
| Dec 15, 1995 | K952490 | IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM Roche Image Analysis Systems | LJM |
| Nov 14, 1995 | K954106 | THERATEST LAB, INC., EL-ANASCR KIT Theratest Laboratories, Inc. | LJM |
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