MOB

Product Code: MOB

Products Classified as MOB

3046

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

Multiple Autoantibodies Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3046

Test System, Antineutrophil Cytoplasmic Antibodies (anca)

Multiple Autoantibodies Immunological Test System.

Pre-market Notifications for MOB

K173792	EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay	Phadia AB
K172582	EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern And EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern	Euroimmun US, Inc.
K172461	AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin	Aesku.Diagnostics GmbH & Co. KG
K161258	NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit	INOVA DIAGNOSTICS, INC.
K140225	ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO	PHADIA US INC.
K112545	QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM	INOVA DIAGNOSTICS, INC.
K100917	FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM	BIOMEDICAL DIAGNOSTICS (BMD) SA
K092601	IMMULISA ANCA SCREEN ELISA	IMMCO DIAGNOSTICS, INC.
K092599	IMMULISA MPO ANTIBODY ELISA	IMMCO DIAGNOSTICS, INC.
K092600	IMMULISA PR3 ANTIBODY ELISA	IMMCO DIAGNOSTICS, INC.
K091860	AESKULISA MPO, MODEL 30-7303US	AESKU.DIAGNOSTICS
K091859	AESKU PR3	AESKU.DIAGNOSTICS
K083850	EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS	EUROIMMUN US INC
K082130	EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)	EUROIMMUN US INC
K070458	MODIFICATION TO FIDIS VASCULITIS, MODEL MX007	BIOMEDICAL DIAGNOSTICS (BMD) SA

Global Unique Device Identification Database

• 00813545023614: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00813545023607: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00813545023591: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00813545023584: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00813545023577: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00817273020266: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00817273020259: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00816879020120: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00816879020113: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
• 00847865011082: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)
• 00847865010955: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)
• 00847865002394: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)
• 00847865000536: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)
• 00847817022357: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)
• 00847817020162: TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA)

Maude Adverse Events

BIO RAD ANCA FORMALIN FIXED IFA SLIDE	IMMCO DIAGNOSTICS, INC.	2012-03-20
ANCA SLIDE	INOVA DIAGNOSTICS, INC.	2000-07-13
NEUTROPHIL SLIDE	INOVA DIAGNOSTICS, INC.	1998-06-26