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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 VIII
Coagulation factor VIII
W0103020207
10 devices
Devices
HemosIL Factor VIII deficient plasma
Instrumentation Laboratory Company
·
,
US
Class C
CE/IVDR
GUDID
on market
sthemO VIII
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
TriniCHROM Factor VIII:c
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDR
CE/IVDD
+1
authorizations
HemosIL Factor VIII deficient plasma
Instrumentation Laboratory Company
·
,
US
Class C
FDA 510(k)
K110237
Active
Cleared 8 Jul 2011
FDA 510(k)
K034007
Active
Cleared 13 Feb 2004
+2
authorizations
BIOPHEN™ FVIII variant
Hyphen Biomed
·
,
FR
Class C
CE/IVDR
STA® - Deficient VIII
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
GUDID
on market
TEClot Factor VIII Deficient Plasma
TECO Medical Instruments, Production + Trading GmbH
·
,
DE
IVD General
CE/IVDD
TriniCLOT Factor VIII
Tcoag ireland ltd
·
,
IE
IVD General
CE/IVDR
CE/IVDD
STA® - ImmunoDef VIII
Diagnostica Stago
·
,
FR
Class B
CE/IVDR
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