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To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in...
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Lead Sponsor
dsm-firmenich Switzerland AG
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Deutsche Klinik für Diagnostik
Wiesbaden, Hesse
Cantonal Hospital -Institue for Clinical Chemistry and hematology
Sankt Gallen, Switzerland
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