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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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Coagulation inhibitors/thrombophilia markers
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Protein c
Protein c
W0103020607
11 devices
Devices
STA® - Stachrom® Protein C
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
GUDID
on market
HemosIL Protein C
Instrumentation Laboratory Company
·
,
US
Class B
FDA 510(k)
K062430
Active
Cleared 1 Sep 2006
CE/IVDR
+1
authorizations
sthemO PC clot M
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
MRX Protein C
Nordic Biomarker AB
·
,
SE
IVD General
CE/IVDD
TriniCLOT PC II
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDD
sthemO PC chrom
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
STA® - Staclot® Protein C 1
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
GUDID
on market
Asserachrom® Protein C
Diagnostica Stago
·
,
FR
IVD General
CE/IVDD
GUDID
on market
HemosIL ProClot diluent
Instrumentation Laboratory Company
·
,
US
Class A
FDA 510(k)
K070635
Active
Cleared 29 Mar 2007
CE/IVDR
+1
authorizations
HemosIL ProClot
Instrumentation Laboratory Company
·
,
US
Class B
CE/IVDR
GUDID
on market
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