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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 factors
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Coagulation factor von willebrand activity / ristocetin cofactor activity (rco)
Coagulation factor von willebrand activity / ristocetin cofactor activity (rco)
W0103020217
5 devices
Devices
Hart Biologicals
Hart Biologicals Ltd.
·
,
GB
IVD General
CE/IVDD
HemosIL VWF:RCo
Biokit, S.A.
·
,
ES
Class B
CE/IVDR
HemosIL AcuStar VWF:RCo
Instrumentation Laboratory Company
·
,
US
Class B
CE/IVDR
HemosIL von Willebrand Factor Activity
Instrumentation Laboratory Company
·
,
US
Class B
FDA 510(k)
K040843
Active
Cleared 30 Apr 2004
CE/IVDR
+1
authorizations
Hart Biologicals
Hart Biologicals Ltd.
·
,
GB
IVD General
CE/IVDD
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