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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 IX
Coagulation factor IX
W0103020208
8 devices
Devices
STA® - Deficient IX
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
GUDID
on market
HemosIL Chromogenic Factor IX
Instrumentation Laboratory Company
·
,
US
Class C
FDA 510(k)
K230852
Active
Cleared 13 Dec 2023
CE/IVDR
HemosIL Factor IX deficient plasma
Instrumentation Laboratory Company
·
,
US
Class C
FDA 510(k)
K031829
Active
Cleared 31 Jul 2003
CE/IVDR
+1
authorizations
TriniCLOT Factor IX
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDD
Asserachrom® IX:Ag
Diagnostica Stago
·
,
FR
IVD General
CE/IVDD
GUDID
on market
sthemO IX
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
TEClot Factor IX Deficient Plasma
TECO Medical Instruments, Production + Trading GmbH
·
,
DE
IVD General
CE/IVDD
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