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510(k) Data Aggregation
K Number
K012755Device Name
AUTODIMER ASSAY MODEL # 1431
Manufacturer
Date Cleared
2002-03-15
(211 days)
Product Code
Regulation Number
864.7320Why did this record match?
Applicant Name (Manufacturer) :
XTRANA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AutoDimer Assay is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation product D-dimer (in human plasma) using the Hitachi 911, Hitachi 902, or Hitachi 717 instruments. Laboratory measurements of D-dimer have been shown to be of significance in the assessment of pulmonary embolism, deep vein thrombosis and disseminated intravascular coagulation.
Device Description
AutoDimer Assay is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation product D-dimer (in human plasma) using the Hitachi 911, Hitachi 902, or Hitachi 717 instruments. AutoDimer Assay utilizes antibody-coated latex particles. The antibody-coated particles are coated with a monoclonal antibody reacting with fibrin D-dimer or fragment D of fibrinogen but not with fibrinogen, allowing D-dimer determination in human plasma.
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