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In vitro diagnostic medical devices
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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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Coagulation inhibitors/thrombophilia markers for heparin induced thrombocytopenia test (hit)
Coagulation inhibitors/thrombophilia markers for heparin induced thrombocytopenia test (hit)
W0103020615
4 devices
Devices
HemosIL HIT-Ab(PF4-H)
Biokit, S.A.
·
,
ES
Class B
FDA 510(k)
K153137
Active
Cleared 8 Jul 2016
CE/IVDR
HemosIL HIT- Ab(PF4-H) Controls
Biokit, S.A.
·
,
ES
Class B
CE/IVDR
Asserachrom® HPIA
Diagnostica Stago
·
,
FR
IVD General
CE/IVDD
GUDID
on market
Asserachrom® HPIA - IgG
Diagnostica Stago
·
,
FR
IVD General
CE/IVDD
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