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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Controls - immunochemistry
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Controls for autoimmunity
Controls for autoimmunity
W0102152011
225 devices
MosaiQ® AiPlex CTD Quality controls
AliveDx Suisse SA
·
,
Switzerland
Class B
CE/IVDR
dsDNA IgG Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
EliA CCP Positive Control 250
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Atellica IM aTgII Quality Control (aTgII QC)
Siemens Healthcare Diagnostics Products Limited
·
,
United Kingdom
Class B
CE/IVDR
GUDID
on market
EliA Calprotectin Positive Control 250
Phadia AB
·
,
Sweden
Class B
CE/IVDR
Anti-β2-Glycoprotein Ⅰ Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Autoimmune Maker Control I
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
Anti-CCP Control Level 1
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
EliA APS Positive Control 250
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
EliA ANCA/GBM Positive Control 2500/5000
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
EliA ANA Positive Control 200
Phadia AB
·
,
Sweden
Class B
CE/IVDR
Autoimmune Maker Control I
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
β2-Glycoprotein I IgG Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
EliA Calprotectin Negative Control 2500/5000
Phadia AB
·
,
Sweden
Class B
CE/IVDR
EliA M2 Positive Control 250
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
Aptiva
Inova Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
β2-Glycoprotein I IgM Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
IMMUNO-TROL APS IgM
Biosynex
·
,
France
IVD General
CE/IVDD
Pathtrol™ Calprotectin B Control Level 1 & 2 & 3 (Trial Pack)
Eurobio Scientific UK Ltd
·
,
United Kingdom
IVD General
CE/IVDD
EliA IgG/IgM/IgA Neg Control 2500/5000
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
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