Panels › Immunology › Product code MOB · Class 2
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Regulation 866.5660
1510(k)s in 12 months (75 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MOB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 2026 | K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM Zeus Scientific | MOB |
| May 7, 2025 | K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) Zeus Scientific | MOB |
| May 24, 2018 | K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern Euroimmun Us, Inc. | MOB |
| Mar 23, 2018 | K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin Aesku.Diagnostics GmbH & Co. KG, DE | MOB |
| Mar 13, 2018 | K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay Phadia AB, SE | MOB |
| Feb 3, 2017 | K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit Inova Diagnostics, Inc. | MOB |
| Oct 27, 2014 | K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO Phadia US, Inc., DE | MOB |
| Jul 31, 2012 | K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM Inova Diagnostics, Inc. | MOB |
| Nov 3, 2010 | K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM Biomedical Diagnostics (Bmd) SA, FR | MOB |
| Oct 7, 2010 | K092601 | IMMULISA ANCA SCREEN ELISA Immco Diagnostics, Inc. | MOB |
| Oct 7, 2010 | K092600 | IMMULISA PR3 ANTIBODY ELISA Immco Diagnostics, Inc. | MOB |
| Oct 7, 2010 | K092599 | IMMULISA MPO ANTIBODY ELISA Immco Diagnostics, Inc. | MOB |
| Jun 3, 2010 | K091859 | AESKU PR3 Aesku Diagnostics, DE | MOB |
| Feb 23, 2010 | K091860 | AESKULISA MPO, MODEL 30-7303US Aesku Diagnostics, DE | MOB |
| May 20, 2009 | K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS Euroimmun Us, Inc. | MOB |
| Apr 7, 2009 | K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) Euroimmun Us, Inc. | MOB |
| Dec 21, 2007 | K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 Biomedical Diagnostics (Bmd) SA, FR | MOB |
| Sep 8, 2006 | K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. Euroimmun Us, LLC | MOB |
| Jul 20, 2006 | K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 Theratest Laboratories, Inc. | MOB |
| Mar 2, 2006 | K053012 | FIDIS VASCULITIS, MODEL MX007 Biomedical Diagnostics (Bmd) SA, FR | MOB |
| Feb 16, 2006 | K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM Euroimmun Us, LLC | MOB |
| Nov 23, 2005 | K051455 | WIESLAB CAP MPO-ANCA Eurodiagnostica | MOB |
| Nov 22, 2005 | K051458 | WIESLAB CAP PR-3 ANCA Eurodiagnostica | MOB |
| May 12, 2005 | K050715 | QUANTA PLEX ANCA PROFILE Inova Diagnostics, Inc. | MOB |
| Jul 2, 2004 | K041043 | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 Pharmacia Deutschland GmbH, DE | MOB |
| Jun 16, 2004 | K041040 | VARELISA MPO ANCA, MODEL 17648/17696 Sweden Diagnostics (Germany) GmbH, DE | MOB |
| Apr 5, 2004 | K040111 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM Zeus Scientific, Inc. | MOB |
| Apr 2, 2004 | K040711 | MESACUP TEST PR-3 Rhigene, Inc. | MOB |
| Mar 22, 2004 | K040586 | MESACUP TEST MPO, MODEL 11053 Rhigene, Inc. | MOB |
| Nov 14, 2001 | K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 Immuno Concepts, Inc. | MOB |
| Nov 14, 2001 | K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 Immuno Concepts, Inc. | MOB |
| Mar 16, 2001 | K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA Scimedx Corp. | MOB |
| Mar 7, 2001 | K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA Scimedx Corp. | MOB |
| Sep 28, 2000 | K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA Cogent Diagnotics , Ltd., GB | MOB |
| Aug 30, 2000 | K001127 | ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY The Binding Site, Ltd. | MOB |
| Apr 28, 1999 | K990796 | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA Cogent Diagnotics , Ltd., GB | MOB |
| Jan 11, 1999 | K984516 | THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET Zeus Scientific, Inc. | MOB |
| Dec 17, 1998 | K984315 | THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE Zeus Scientific, Inc. | MOB |
| Nov 30, 1998 | K984034 | THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR Zeus Scientific, Inc. | MOB |
| Nov 30, 1998 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM Immco Diagnostics, Inc. | MOB |
| Nov 18, 1998 | K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | MOB |
| Nov 18, 1998 | K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. | MOB |
| Jul 22, 1998 | K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM Wieslab AB | MOB |
| Jul 22, 1998 | K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM Wieslab AB | MOB |
| Jul 20, 1998 | K981030 | BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. | MOB |
| Jul 20, 1998 | K981029 | BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT The Binding Site, Ltd. | MOB |
| Jun 19, 1998 | K981330 | QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT Inova Diagnostics, Inc. | MOB |
| Jun 19, 1998 | K981328 | QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT Inova Diagnostics, Inc. | MOB |
| Feb 17, 1998 | K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA American Laboratory Products Co., Ltd. | MOB |
| Feb 17, 1998 | K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA American Laboratory Products Co., Ltd. | MOB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.