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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Markers for auto-immune diseases
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Vasculitis
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Anca screening
Anca screening
W0102100401
20 devices
Devices
NOVA Lite
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
NOVA Lite
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
BlueDiverDot ANCA+GBM IgG
D-tek s.a.
·
,
BE
Class B
CE/IVDR
NOVA Lite
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Vasculitis – ANCA + GBM Dot
D-tek s.a.
·
,
BE
Class B
CE/IVDR
DIAspot Neptune ANCA+GBM IgG
D-tek s.a.
·
,
BE
Class B
CE/IVDR
BlueDot ANCA+GBM IgG
D-tek s.a.
·
,
BE
Class B
CE/IVDD
CE/IVDR
NOVA Lite
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Vasculitis - ANCA+GBM
D-tek s.a.
·
,
BE
Class B
CE/IVDR
DIASpot ANCA+GBM IgG
D-tek s.a.
·
,
BE
Class B
CE/IVDR
NOVA Lite
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Diagnostic Kit for ANCA (Formalin)(IFA)
Guangzhou Kangrun Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis
HOB Biotech Group Corp., Ltd.
·
,
CN
IVD General
CE/IVDD
NOVA Lite
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
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