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510(k) Data Aggregation
K Number
K040362Device Name
DIAPHARMA FACTOR X KIT
Manufacturer
DIAPHARMA GROUP, INC.
Date Cleared
2004-07-12
(150 days)
Product Code
GJT
Regulation Number
864.7290Why did this record match?
Applicant Name (Manufacturer) :
DIAPHARMA GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DiaPharma Factor X Kit is an in vitro diagnostic test kit for the quantitative determination of Factor X activity in human citrated plasma.
Factor X activity is useful for monitoring patients on oral anticoagulant therapy (warfarin) where baseline PT values may be prolonged and INR results are not reliable, such as in OAC patients with lupus inhibitors. The DiaPharma FX kit provides health care providers with a tool for with Tapac Innovelor The DiaPharma Factor X Kit is also useful for screening for factor X deficiencies.
Device Description
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