EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNO CONCEPTS ANCA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

VARELISA MPO-ANCA

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM

FDA 510(k)

FDA Class 2 ·Immunology

MESACUP TEST PR-3

FDA 510(k)

FDA Class 2 ·Immunology

MYELOPEROXIDASE ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PR-3 ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

AESKU PR3

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Immunology

FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNO CONCEPTS ANCA TEST SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE PR3

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO FIDIS VASCULITIS, MODEL MX007

FDA 510(k)

FDA Class 2 ·Immunology

IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM

FDA 510(k)

FDA Class 2 ·Immunology

Polypropylene Mob Cap

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Uhealth Medical (Beijing) Products Co., Ltd.·5 devices

Non Sterile Mob Caps

Basic UDI-DI

EU MDR · Eu Md Class 1 ·RAYS S.p.A.·1 device

BioPlex 2200 Vasculitis Control Set

FDA registration

BIO-RAD LABORATORIES, INC.·4 products·🇺🇸 United States

QUANTA Flash MPO Calibrators

FDA registration

INSTRUMENTATION LABORATORY SPA·4 products·🇮🇹 Italy

QUANTA Flash PR3 Calibrators

FDA registration

INOVA DIAGNOSTICS, INC.·4 products·🇺🇸 United States