FDA Product Code
FDA Product Code MOB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 75 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM | Zeus Scientific | 2026-08-21 | Traditional | PDF ↗ |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific | 2025-05-07 | Traditional | PDF ↗ |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern | Euroimmun Us, Inc. | 2018-05-24 | Traditional | PDF ↗ |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 | Traditional | PDF ↗ |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | Phadia AB | 2018-03-13 | Traditional | PDF ↗ |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | Inova Diagnostics, Inc. | 2017-02-03 | Traditional | PDF ↗ |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | Phadia US, Inc. | 2014-10-27 | Traditional | PDF ↗ |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | Inova Diagnostics, Inc. | 2012-07-31 | Traditional | PDF ↗ |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | Biomedical Diagnostics (Bmd) SA | 2010-11-03 | Special | PDF ↗ |
| K092599 | IMMULISA MPO ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 | Traditional | PDF ↗ |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 | Traditional | PDF ↗ |
| K092601 | IMMULISA ANCA SCREEN ELISA | Immco Diagnostics, Inc. | 2010-10-07 | Traditional | PDF ↗ |
| K091859 | AESKU PR3 | Aesku Diagnostics | 2010-06-03 | Traditional | PDF ↗ |
| K091860 | AESKULISA MPO, MODEL 30-7303US | Aesku Diagnostics | 2010-02-23 | Traditional | PDF ↗ |
| K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | Euroimmun Us, Inc. | 2009-05-20 | Traditional | PDF ↗ |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-07 | Traditional | PDF ↗ |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2007-12-21 | Traditional | PDF ↗ |
| K060700 | EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. | Euroimmun Us, LLC | 2006-09-08 | Traditional | PDF ↗ |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | Theratest Laboratories, Inc. | 2006-07-20 | Traditional | PDF ↗ |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2006-03-02 | Traditional | PDF ↗ |
| K051489 | EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM | Euroimmun Us, LLC | 2006-02-16 | Traditional | PDF ↗ |
| K051455 | WIESLAB CAP MPO-ANCA | Eurodiagnostica | 2005-11-23 | Traditional | PDF ↗ |
| K051458 | WIESLAB CAP PR-3 ANCA | Eurodiagnostica | 2005-11-22 | Traditional | PDF ↗ |
| K050715 | QUANTA PLEX ANCA PROFILE | Inova Diagnostics, Inc. | 2005-05-12 | Traditional | PDF ↗ |
| K041043 | VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 | Pharmacia Deutschland GmbH | 2004-07-02 | Traditional | PDF ↗ |
| K041040 | VARELISA MPO ANCA, MODEL 17648/17696 | Sweden Diagnostics (Germany) GmbH | 2004-06-16 | Traditional | PDF ↗ |
| K040111 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM | Zeus Scientific, Inc. | 2004-04-05 | Traditional | PDF ↗ |
| K040711 | MESACUP TEST PR-3 | Rhigene, Inc. | 2004-04-02 | Traditional | PDF ↗ |
| K040586 | MESACUP TEST MPO, MODEL 11053 | Rhigene, Inc. | 2004-03-22 | Traditional | PDF ↗ |
| K013285 | RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 | Immuno Concepts, Inc. | 2001-11-14 | Traditional | PDF ↗ |
| K013283 | RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 | Immuno Concepts, Inc. | 2001-11-14 | Traditional | PDF ↗ |
| K010287 | SCIMEDX PHASE II PR3 IGG ANTIBODY EIA | Scimedx Corp. | 2001-03-16 | Traditional | PDF ↗ |
| K010289 | SCIMEDX PHASE II MPO IGG ANTIBODY EIA | Scimedx Corp. | 2001-03-07 | Traditional | PDF ↗ |
| K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | Cogent Diagnotics , Ltd. | 2000-09-28 | Traditional | PDF ↗ |
| K001127 | ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY | The Binding Site, Ltd. | 2000-08-30 | Traditional | PDF ↗ |
| K990796 | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | Traditional | PDF ↗ |
| K984516 | THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET | Zeus Scientific, Inc. | 1999-01-11 | Traditional | PDF ↗ |
| K984315 | THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE | Zeus Scientific, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K984034 | THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | 1998-11-30 | Traditional | PDF ↗ |
| K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | Immco Diagnostics, Inc. | 1998-11-30 | Traditional | PDF ↗ |
| K983740 | IS-ANTI-PR3 IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K983390 | IS-ANTI-MPO IGG ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | Wieslab AB | 1998-07-22 | Traditional | PDF ↗ |
| K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM | Wieslab AB | 1998-07-22 | Traditional | PDF ↗ |
| K981030 | BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 1998-07-20 | Traditional | PDF ↗ |
| K981029 | BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 1998-07-20 | Traditional | PDF ↗ |
| K981330 | QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT | Inova Diagnostics, Inc. | 1998-06-19 | Traditional | PDF ↗ |
| K981328 | QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT | Inova Diagnostics, Inc. | 1998-06-19 | Traditional | PDF ↗ |
| K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA | American Laboratory Products Co., Ltd. | 1998-02-17 | Traditional | PDF ↗ |
| K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA | American Laboratory Products Co., Ltd. | 1998-02-17 | Traditional | PDF ↗ |
| K974166 | WIELISA MPO ANCA TEST SYSTEM | Wieslab AB | 1998-02-17 | Traditional | PDF ↗ |
| K974167 | WIELISA PR-3 ANCA TEST SYSTEM | Wieslab AB | 1998-02-17 | Traditional | PDF ↗ |
| K974463 | IMMUNO CONCEPTS ANCA TEST SYSTEM | Immuno Concepts, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K974478 | IMMUNO CONCEPTS ANCA TEST SYSTEMS | Immuno Concepts, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K973822 | VIRGO ANCA SCREEN KIT | Hemagen Diagnostics, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K973824 | VIRGO PANCO KIT | Hemagen Diagnostics, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K973823 | PR 3 ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | Euro-Diagnostica AB | 1997-10-29 | Traditional | PDF ↗ |
| K971690 | IMMUNOSCAN PR3-ANCA | Euro-Diagnostica AB | 1997-10-29 | Traditional | PDF ↗ |
| K965133 | ANCA COMBI DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1997-05-21 | Traditional | PDF ↗ |
| K964449 | ANCA SCREEN ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-04-10 | Traditional | PDF ↗ |
| K964448 | PROTEINASE-3 IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-04-10 | Traditional | PDF ↗ |
| K964446 | MYELOPEROXIDASE ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-04-10 | Traditional | PDF ↗ |
| K962360 | IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES | Scimedx Corp. | 1996-09-30 | Traditional | PDF ↗ |
| K961764 | PR-3 ELISA TEST SYSTEM | Immunoprobe, Inc. | 1996-08-19 | Traditional | PDF ↗ |
| K961765 | MPO ELISA TEST SYSTEM | Immunoprobe, Inc. | 1996-08-19 | Traditional | PDF ↗ |
| K961340 | NOVA LITE ANCA | Inova Diagnostics, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K955022 | QUANTA LITE MPO | Inova Diagnostics, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K954062 | EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES | Scimedx Corp. | 1996-03-19 | Traditional | PDF ↗ |
| K955021 | QUANTA LITE PR3 | Inova Diagnostics, Inc. | 1996-03-19 | Traditional | PDF ↗ |
| K954105 | EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES | Scimedx Corp. | 1996-03-19 | Traditional | PDF ↗ |
| K953586 | VARELISA PR3-ANCA | Elias U.S.A., Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K953587 | VARELISA MPO-ANCA | Elias U.S.A., Inc. | 1996-01-26 | Traditional | PDF ↗ |
| K942813 | DIASTAT ANTI-PR3 (C-ANCA) KIT | Shield Diagnostics, Ltd. | 1995-03-06 | Traditional | PDF ↗ |
| K943630 | DIASTAT ANTI-MPO (PANCA) KIT | Shield Diagnostics, Ltd. | 1995-03-06 | Traditional | PDF ↗ |
Product code MOB · Class II · Immunology. Data: openFDA.