Atlas FDA

MOB

74 FDA 510(k) clearances · Product code

123 daysmedian time to decision
271 days90th percentile
74clearances measured

FDA profile

Official device name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Medical specialty
Immunology
Flags
Third-party review eligible
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RecordFirmDate
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (K243776)Zeus Scientific2025-05-07
EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern (K172582)Euroimmun Us, Inc.2018-05-24
AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (K172461)Aesku.Diagnostics GmbH & Co. KG2018-03-23
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (K173792)Phadia AB2018-03-13
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (K161258)Inova Diagnostics, Inc.2017-02-03
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO (K140225)Phadia US, Inc.2014-10-27
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (K112545)Inova Diagnostics, Inc.2012-07-31
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (K100917)Biomedical Diagnostics (Bmd) SA2010-11-03
IMMULISA PR3 ANTIBODY ELISA (K092600)Immco Diagnostics, Inc.2010-10-07
IMMULISA ANCA SCREEN ELISA (K092601)Immco Diagnostics, Inc.2010-10-07
IMMULISA MPO ANTIBODY ELISA (K092599)Immco Diagnostics, Inc.2010-10-07
AESKU PR3 (K091859)Aesku Diagnostics2010-06-03
AESKULISA MPO, MODEL 30-7303US (K091860)Aesku Diagnostics2010-02-23
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS (K083850)Euroimmun Us, Inc.2009-05-20
EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) (K082130)Euroimmun Us, Inc.2009-04-07
MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 (K070458)Biomedical Diagnostics (Bmd) SA2007-12-21
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT. (K060700)Euroimmun Us, LLC2006-09-08
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 (K061376)Theratest Laboratories, Inc.2006-07-20
FIDIS VASCULITIS, MODEL MX007 (K053012)Biomedical Diagnostics (Bmd) SA2006-03-02
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM (K051489)Euroimmun Us, LLC2006-02-16
WIESLAB CAP MPO-ANCA (K051455)Eurodiagnostica2005-11-23
WIESLAB CAP PR-3 ANCA (K051458)Eurodiagnostica2005-11-22
QUANTA PLEX ANCA PROFILE (K050715)Inova Diagnostics, Inc.2005-05-12
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 (K041043)Pharmacia Deutschland GmbH2004-07-02
VARELISA MPO ANCA, MODEL 17648/17696 (K041040)Sweden Diagnostics (Germany) GmbH2004-06-16
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM (K040111)Zeus Scientific, Inc.2004-04-05
MESACUP TEST PR-3 (K040711)Rhigene, Inc.2004-04-02
MESACUP TEST MPO, MODEL 11053 (K040586)Rhigene, Inc.2004-03-22
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (K013285)Immuno Concepts, Inc.2001-11-14
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (K013283)Immuno Concepts, Inc.2001-11-14
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (K010287)Scimedx Corp.2001-03-16
SCIMEDX PHASE II MPO IGG ANTIBODY EIA (K010289)Scimedx Corp.2001-03-07
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA (K002215)Cogent Diagnotics , Ltd.2000-09-28
ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY (K001127)The Binding Site, Ltd.2000-08-30
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA (K990796)Cogent Diagnotics , Ltd.1999-04-28
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET (K984516)Zeus Scientific, Inc.1999-01-11
THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE (K984315)Zeus Scientific, Inc.1998-12-17
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM (K982898)Immco Diagnostics, Inc.1998-11-30
THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984034)Zeus Scientific, Inc.1998-11-30
IS-ANTI-PR3 IGG ELISA TEST SYSTEM (K983740)Columbia Bioscience, Inc.1998-11-18
IS-ANTI-MPO IGG ELISA TEST SYSTEM (K983390)Columbia Bioscience, Inc.1998-11-18
WIELISA ANCA SCREENING KIT TEST SYSTEM (K981748)Wieslab AB1998-07-22
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM (K981750)Wieslab AB1998-07-22
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT (K981030)The Binding Site, Ltd.1998-07-20
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT (K981029)The Binding Site, Ltd.1998-07-20
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT (K981330)Inova Diagnostics, Inc.1998-06-19
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT (K981328)Inova Diagnostics, Inc.1998-06-19
WIELISA MPO ANCA TEST SYSTEM (K974166)Wieslab AB1998-02-17
ORGENTEC ANTI-MPO (P-ANCA) ELISA (K974701)American Laboratory Products Co., Ltd.1998-02-17
WIELISA PR-3 ANCA TEST SYSTEM (K974167)Wieslab AB1998-02-17
ORGENTEC ANTI-PR3 (C-ANCA) ELISA (K974702)American Laboratory Products Co., Ltd.1998-02-17
IMMUNO CONCEPTS ANCA TEST SYSTEM (K974463)Immuno Concepts, Inc.1998-02-09
IMMUNO CONCEPTS ANCA TEST SYSTEMS (K974478)Immuno Concepts, Inc.1998-02-09
VIRGO PANCO KIT (K973824)Hemagen Diagnostics, Inc.1997-11-13
PR 3 ANTIBODY KIT (K973823)Hemagen Diagnostics, Inc.1997-11-13
VIRGO ANCA SCREEN KIT (K973822)Hemagen Diagnostics, Inc.1997-11-13
IMMUNOSCAN PR3-ANCA (K971690)Euro-Diagnostica AB1997-10-29
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT (K971689)Euro-Diagnostica AB1997-10-29
ANCA COMBI DIAGNOSTIC TEST KIT (K965133)The Binding Site, Ltd.1997-05-21
MYELOPEROXIDASE ELISA TEST SYSTEM (K964446)Zeus Scientific, Inc.1997-04-10
ANCA SCREEN ELISA TEST SYSTEM (K964449)Zeus Scientific, Inc.1997-04-10
PROTEINASE-3 IGG ELISA TEST SYSTEM (K964448)Zeus Scientific, Inc.1997-04-10
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (K962360)Scimedx Corp.1996-09-30
MPO ELISA TEST SYSTEM (K961765)Immunoprobe, Inc.1996-08-19
PR-3 ELISA TEST SYSTEM (K961764)Immunoprobe, Inc.1996-08-19
NOVA LITE ANCA (K961340)Inova Diagnostics, Inc.1996-07-10
QUANTA LITE PR3 (K955021)Inova Diagnostics, Inc.1996-03-19
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES (K954105)Scimedx Corp.1996-03-19
QUANTA LITE MPO (K955022)Inova Diagnostics, Inc.1996-03-19
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES (K954062)Scimedx Corp.1996-03-19
VARELISA MPO-ANCA (K953587)Elias U.S.A., Inc.1996-01-26
VARELISA PR3-ANCA (K953586)Elias U.S.A., Inc.1996-01-26
DIASTAT ANTI-PR3 (C-ANCA) KIT (K942813)Shield Diagnostics, Ltd.1995-03-06
DIASTAT ANTI-MPO (PANCA) KIT (K943630)Shield Diagnostics, Ltd.1995-03-06

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