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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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Apc resistance
Apc resistance
W0103020610
5 devices
Devices
Pefakit® APC-R Faktor V Leiden
Pentapharm AG
·
,
CH
IVD General
CE/IVDD
Pefakit® APC-R Factor V Leiden Controls
Pentapharm AG
·
,
CH
IVD General
FDA 510(k)
K042762
Active
Cleared 22 Dec 2004
FDA 510(k)
K042760
Active
Cleared 22 Dec 2004
+1
authorizations
HemosIL Factor V Leiden (APC Resistance V)
Instrumentation Laboratory Company
·
,
US
Class B
FDA 510(k)
K260551
Active
Cleared 20 Mar 2026
CE/IVDR
+1
authorizations
APCr
Pentapharm AG
·
,
CH
IVD General
CE/IVDD
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