Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA product code MOB · 74 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.5660
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1995-03-06 – 2026-08-21

MOB 2026-08-21

Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM

Applicant Zeus Scientific

K number K261466

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MOB 2025-05-07

Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)

Applicant Zeus Scientific

K number K243776

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MOB 2018-05-24

EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern

Applicant Euroimmun Us, Inc.

K number K172582

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MOB 2018-03-23

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

Applicant Aesku.Diagnostics GmbH & Co. KG

K number K172461

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MOB 2018-03-13

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

Applicant Phadia AB

K number K173792

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MOB 2017-02-03

NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit

Applicant Inova Diagnostics, Inc.

K number K161258

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MOB 2012-07-31

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

Applicant Inova Diagnostics, Inc.

K number K112545

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MOB 2010-11-03

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

Applicant Biomedical Diagnostics (Bmd) SA

K number K100917

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MOB 2010-10-07

IMMULISA ANCA SCREEN ELISA

Applicant Immco Diagnostics, Inc.

K number K092601

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MOB 2010-10-07

IMMULISA PR3 ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K092600

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MOB 2010-10-07

IMMULISA MPO ANTIBODY ELISA

Applicant Immco Diagnostics, Inc.

K number K092599

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MOB 2010-06-03

AESKU PR3

Applicant Aesku Diagnostics

K number K091859

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MOB 2010-02-23

AESKULISA MPO, MODEL 30-7303US

Applicant Aesku Diagnostics

K number K091860

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MOB 2009-05-20

EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS

Applicant Euroimmun Us, Inc.

K number K083850

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MOB 2009-04-07

EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)

Applicant Euroimmun Us, Inc.

K number K082130

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MOB 2007-12-21

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

Applicant Biomedical Diagnostics (Bmd) SA

K number K070458

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MOB 2006-09-08

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

Applicant Euroimmun Us, LLC

K number K060700

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MOB 2006-07-20

EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3

Applicant Theratest Laboratories, Inc.

K number K061376

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MOB 2006-03-02

FIDIS VASCULITIS, MODEL MX007

Applicant Biomedical Diagnostics (Bmd) SA

K number K053012

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MOB 2006-02-16

EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

Applicant Euroimmun Us, LLC

K number K051489

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MOB 2005-11-23

WIESLAB CAP MPO-ANCA

Applicant Eurodiagnostica

K number K051455

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MOB 2005-11-22

WIESLAB CAP PR-3 ANCA

Applicant Eurodiagnostica

K number K051458

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MOB 2005-05-12

QUANTA PLEX ANCA PROFILE

Applicant Inova Diagnostics, Inc.

K number K050715

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MOB 2004-07-02

VARELISA PR3 ANCA, MODEL NUMBER 17748/17796

Applicant Pharmacia Deutschland GmbH

K number K041043

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MOB 2004-06-16

VARELISA MPO ANCA, MODEL 17648/17696

Applicant Sweden Diagnostics (Germany) GmbH

K number K041040

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MOB 2004-04-05

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K040111

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MOB 2004-04-02

MESACUP TEST PR-3

Applicant Rhigene, Inc.

K number K040711

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MOB 2004-03-22

MESACUP TEST MPO, MODEL 11053

Applicant Rhigene, Inc.

K number K040586

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MOB 2001-11-14

RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15

Applicant Immuno Concepts, Inc.

K number K013285

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MOB 2001-11-14

RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16

Applicant Immuno Concepts, Inc.

K number K013283

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MOB 2001-03-16

SCIMEDX PHASE II PR3 IGG ANTIBODY EIA

Applicant Scimedx Corp.

K number K010287

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MOB 2001-03-07

SCIMEDX PHASE II MPO IGG ANTIBODY EIA

Applicant Scimedx Corp.

K number K010289

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MOB 2000-09-28

AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA

Applicant Cogent Diagnotics , Ltd.

K number K002215

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MOB 2000-08-30

ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY

Applicant The Binding Site, Ltd.

K number K001127

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MOB 1999-04-28

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA

Applicant Cogent Diagnotics , Ltd.

K number K990796

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MOB 1999-01-11

THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET

Applicant Zeus Scientific, Inc.

K number K984516

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MOB 1998-12-17

THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE

Applicant Zeus Scientific, Inc.

K number K984315

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MOB 1998-11-30

THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

Applicant Zeus Scientific, Inc.

K number K984034

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MOB 1998-11-30

IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM

Applicant Immco Diagnostics, Inc.

K number K982898

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MOB 1998-11-18

IS-ANTI-PR3 IGG ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K983740

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MOB 1998-11-18

IS-ANTI-MPO IGG ELISA TEST SYSTEM

Applicant Columbia Bioscience, Inc.

K number K983390

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MOB 1998-07-22

WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM

Applicant Wieslab AB

K number K981750

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MOB 1998-07-22

WIELISA ANCA SCREENING KIT TEST SYSTEM

Applicant Wieslab AB

K number K981748

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MOB 1998-07-20

BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT

Applicant The Binding Site, Ltd.

K number K981030

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MOB 1998-07-20

BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT

Applicant The Binding Site, Ltd.

K number K981029

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MOB 1998-06-19

QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT

Applicant Inova Diagnostics, Inc.

K number K981330

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MOB 1998-06-19

QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT

Applicant Inova Diagnostics, Inc.

K number K981328

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MOB 1998-02-17

ORGENTEC ANTI-PR3 (C-ANCA) ELISA

Applicant American Laboratory Products Co., Ltd.

K number K974702

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MOB 1998-02-17

ORGENTEC ANTI-MPO (P-ANCA) ELISA

Applicant American Laboratory Products Co., Ltd.

K number K974701

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MOB 1998-02-17

WIELISA PR-3 ANCA TEST SYSTEM

Applicant Wieslab AB

K number K974167

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MOB 1998-02-17

WIELISA MPO ANCA TEST SYSTEM

Applicant Wieslab AB

K number K974166

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MOB 1998-02-09

IMMUNO CONCEPTS ANCA TEST SYSTEMS

Applicant Immuno Concepts, Inc.

K number K974478

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MOB 1998-02-09

IMMUNO CONCEPTS ANCA TEST SYSTEM

Applicant Immuno Concepts, Inc.

K number K974463

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MOB 1997-11-13

VIRGO PANCO KIT

Applicant Hemagen Diagnostics, Inc.

K number K973824

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MOB 1997-11-13

PR 3 ANTIBODY KIT

Applicant Hemagen Diagnostics, Inc.

K number K973823

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MOB 1997-11-13

VIRGO ANCA SCREEN KIT

Applicant Hemagen Diagnostics, Inc.

K number K973822

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MOB 1997-10-29

IMMUNOSCAN PR3-ANCA

Applicant Euro-Diagnostica AB

K number K971690

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MOB 1997-10-29

IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT

Applicant Euro-Diagnostica AB

K number K971689

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MOB 1997-05-21

ANCA COMBI DIAGNOSTIC TEST KIT

Applicant The Binding Site, Ltd.

K number K965133

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MOB 1997-04-10

ANCA SCREEN ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K964449

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MOB 1997-04-10

PROTEINASE-3 IGG ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K964448

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MOB 1997-04-10

MYELOPEROXIDASE ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K964446

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MOB 1996-09-30

IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES

Applicant Scimedx Corp.

K number K962360

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MOB 1996-08-19

MPO ELISA TEST SYSTEM

Applicant Immunoprobe, Inc.

K number K961765

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MOB 1996-08-19

PR-3 ELISA TEST SYSTEM

Applicant Immunoprobe, Inc.

K number K961764

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MOB 1996-07-10

NOVA LITE ANCA

Applicant Inova Diagnostics, Inc.

K number K961340

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MOB 1996-03-19

QUANTA LITE MPO

Applicant Inova Diagnostics, Inc.

K number K955022

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MOB 1996-03-19

QUANTA LITE PR3

Applicant Inova Diagnostics, Inc.

K number K955021

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MOB 1996-03-19

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES

Applicant Scimedx Corp.

K number K954105

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MOB 1996-03-19

EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES

Applicant Scimedx Corp.

K number K954062

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MOB 1996-01-26

VARELISA MPO-ANCA

Applicant Elias U.S.A., Inc.

K number K953587

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MOB 1996-01-26

VARELISA PR3-ANCA

Applicant Elias U.S.A., Inc.

K number K953586

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MOB 1995-03-06

DIASTAT ANTI-MPO (PANCA) KIT

Applicant Shield Diagnostics, Ltd.

K number K943630

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MOB 1995-03-06

DIASTAT ANTI-PR3 (C-ANCA) KIT

Applicant Shield Diagnostics, Ltd.

K number K942813

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