Panels › Immunology › Product code LLL · Class 2
Extractable Antinuclear Antibody, Antigen And Control
Regulation 866.5100
2510(k)s in 12 months (182 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in LLL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2026 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La Immunodiagnostics Systems Limited, GB | LLL |
| Jun 25, 2026 | K253367 | EliA CTD 13 Screen Phadia AB, SE | LLL |
| Oct 22, 2025 | K250666 | Alegria Flash CTD Screen Zeus Scientific | LLL |
| Sep 19, 2025 | K250408 | Alegria Flash ENA Screen Zeus Scientific | LLL |
| Sep 29, 2023 | K213403 | Aptiva CTD Essential Reagent Inova Diagnostics, Inc. | LLL |
| Nov 29, 2019 | K190710 | EliA SymphonyS Immunoassay Phadia AB, SE | LLL |
| Jun 25, 2018 | K180975 | QUANTA Flash HMGCR Reagents Inova Diagnostics, Inc. | LLL |
| Jun 1, 2016 | K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls Inova Diagnostics, Inc. | LLL |
| Feb 12, 2016 | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols Inova Diagnostics, Inc. | LLL |
| Mar 31, 2015 | K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody EL Immco Diagnostics, Inc. | LLL |
| Feb 12, 2015 | K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS Inova Diagnostics, Inc. | LLL |
| Jan 29, 2015 | K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS Inova Diagnostics, Inc. | LLL |
| May 7, 2013 | K122923 | QUANTA FLASH ENA7 Inova Diagnostics, Inc. | LLL |
| Apr 9, 2013 | K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) Euroimmun US | LLL |
| Dec 2, 2011 | K113143 | IMMULISA SCI-70 ANTIBODY ELISA Immco Diagnostics, Inc. | LLL |
| Dec 3, 2010 | K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS Biomedical Diagnostics (Bmd) SA, FR | LLL |
| Jan 15, 2008 | K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 Phadia US, Inc. | LLL |
| Mar 13, 2006 | K053653 | FIDIS CONNECTIVE 10, MODEL MX006 Biomedical Diagnostics (Bmd) SA, FR | LLL |
| Oct 3, 2005 | K050286 | FIDIS CONNECTIVE 8 Biomedical Diagnostics (Bmd) SA, FR | LLL |
| May 31, 2005 | K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 Bioarray Solutions, Ltd. | LLL |
| Jul 14, 2004 | K041753 | AESKULISA ENA 6 S Aesku Diagnostics | LLL |
| Mar 8, 2004 | K040160 | QUANTA PLEX SLE PROFILE 8 Inova Diagnostics, Inc. | LLL |
| Dec 22, 2003 | K033528 | MESACUP-2 TEST JO-1, MODEL 10756 Rhigene, Inc. | LLL |
| Dec 16, 2003 | K032469 | AESKULISA ANA 8PRO Aesku, Inc. | LLL |
| Jun 25, 2003 | K031450 | QUANTA PLEX ENA PROFILE 6 Inova Diagnostics, Inc. | LLL |
| Apr 24, 2003 | K030681 | QUANTA PLEX ENA PROFILE 5 Inova Diagnostics, Inc. | LLL |
| Jul 27, 2001 | K011140 | QUANTA PLEX ENA PROFILE 4 Inova Diagnostics, Inc. | LLL |
| Mar 1, 2001 | K010147 | ENA EIA KIT The Binding Site, Ltd. | LLL |
| Mar 1, 2001 | K010146 | ENA EIA KIT RANGE The Binding Site, Ltd. | LLL |
| Feb 23, 2001 | K010148 | ENA SCREEN EIA KIT The Binding Site, Ltd. | LLL |
| Oct 13, 2000 | K003057 | AUTOSTAT II ENA-4 PROFILE ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Oct 13, 2000 | K003054 | AUTOSTAT II ENA-6 PROFILE ELISA Cogent Diagnotics , Ltd., GB | LLL |
| May 9, 2000 | K000751 | RHIGENE MESACUP2 TEST- SSB Rhigene, Inc. | LLL |
| May 9, 2000 | K000750 | RHIGENE MESACUP2 TEST- SCL-70 Rhigene, Inc. | LLL |
| May 9, 2000 | K000749 | RHIGENE MESACUP2 TEST- SSA Rhigene, Inc. | LLL |
| Apr 5, 2000 | K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST Helix Diagnostics, Inc. | LLL |
| Jan 12, 2000 | K993839 | ENA PROFILE ELISA TEST SYSTEM Trinity Biotech USA | LLL |
| Jan 11, 2000 | K994029 | MDI SM TEST Micro Detect, Inc. | LLL |
| Jan 11, 2000 | K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM Micro Detect, Inc. | LLL |
| Jun 17, 1999 | K991657 | QUANTA LITE ANA ELISA Inova Diagnostics, Inc. | LLL |
| Apr 28, 1999 | K990798 | AUTOSTAT II ANTI-JO-1 ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990797 | AUTOSTAT II ANTI-SCL-70 ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Dec 28, 1998 | K983921 | AUTOSTAT II ENA SCREEN ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Dec 22, 1998 | K984462 | LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 Bio-Rad | LLL |
| Nov 18, 1998 | K983464 | THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LLL |
| Nov 18, 1998 | K983426 | THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC Zeus Scientific, Inc. | LLL |
| Nov 18, 1998 | K983425 | THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET Zeus Scientific, Inc. | LLL |
| Nov 18, 1998 | K983423 | THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. | LLL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.