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In vitro diagnostic medical devices
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Reagents
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Haematology / haemostasis / immunohaematology / histology / cytology
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Haemostasis reagents (coagulation)
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Platelet factors
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Platelet factor 4
Platelet factor 4
W0103020402
8 devices
Devices
HemosIL AcuStar HIT-IgG(PF4-H)
Open recall
Instrumentation Laboratory Company
·
,
US
Class B
FDA 510(k)
K170854
Active
Cleared 8 Sep 2017
CE/IVDR
PF4 Concentrated Wash
Immucor GTI Diagnostics, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
Asserachrom® PF4
Diagnostica Stago
·
,
FR
IVD General
CE/IVDD
GUDID
on market
Specimen Diluent
Immucor GTI Diagnostics, Inc.
·
,
US
Class A
CE/IVDR
GUDID
on market
STic EXPERT HIT 5/20
Milenia Biotec GmbH
·
,
DE
IVD General
CE/IVDD
STic Expert HIT 5
Milenia Biotec GmbH
·
,
DE
IVD General
CE/IVDD
Milenia QuickLine HIT
Milenia Biotec GmbH
·
,
DE
IVD General
CE/IVDD
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