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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
Vasculitis
W01021004
93 devices
Subcategories
4
W0102100401
Anca screening
20
devices
W0102100402
Mpo anca
26
devices
W0102100403
Pr3 anca
24
devices
W0102100499
Vasculitis - other
23
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
Anti-MPO IgG CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
CN
Class B
CE/MDR
Chorus Mpo
Diesse Diagnostica Senese S.P.A
·
,
IT
Class B
CE/IVDR
QUANTA Flash
Inova Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Anti-MPO IgG CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
CN
Class B
CE/IVDR
BioCLIA Autoimmune Control Set, MPO
HOB Biotech Group Corp., Ltd.
·
,
CN
IVD General
CE/IVDD
EliA MPOS Well
Phadia AB
·
,
SE
Class B
CE/IVDR
GUDID
on market
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