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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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Tdm/drug controls
Tdm/drug controls
W0102152001
85 devices
Devices
Mycophenolic Acid Control Level 3
More Diagnostics Inc
·
,
US
Class C
CE/IVDR
GUDID
on market
invitrol Drugs L-2
invicon diagnostic concepts GmbH
·
,
DE
IVD General
CE/IVDD
invitrol Drugs L-4
invicon diagnostic concepts GmbH
·
,
DE
IVD General
CE/IVDD
SYNCHRON Systems DAT Multi-Drug Low Urine Control
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
IMMUNO-TROL Anti-Vedolizumab
Biosynex
·
,
FR
IVD General
CE/IVDD
IMMUNO-TROL Golimumab
Biosynex
·
,
FR
IVD General
CE/IVDD
IMMUNO-TROL i-Tracker Anti-Risankizumab
Biosynex
·
,
FR
Class B
CE/IVDR
CEDIA Speciality Control Set
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
invitrol® Tox liquid Kombi
invicon diagnostic concepts GmbH
·
,
DE
IVD General
CE/IVDD
IMMUNO-TROL Anti-Infliximab
Biosynex
·
,
FR
IVD General
CE/IVDD
IMMUNO-TROL i-Tracker Ocrelizumab
Biosynex
·
,
FR
Class B
CE/IVDR
IMMUNO-TROL Ustekinumab
Biosynex
·
,
FR
IVD General
CE/IVDD
IMMUNO-TROL i-Tracker Infliximab
Biosynex
·
,
FR
IVD General
CE/IVDD
VALIDATE® TDM1 Test Set
LGC Clinical Diagnostics, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
IMMUNO-TROL Anti-Bevacizumab
Biosynex
·
,
FR
IVD General
CE/IVDD
Drug of Abuse Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
invitrol® TDM liquid L-1
invicon diagnostic concepts GmbH
·
,
DE
IVD General
CE/IVDD
ARCHITECT TDM Multiconstituent Calibrator
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab
Biosynex
·
,
FR
Class B
CE/IVDR
IMMUNO-TROL i-Tracker Anti-Ustekinumab
Biosynex
·
,
FR
IVD General
CE/IVDD
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