Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay.
GEORGE KING BIO-MEDICAL, INC
0001-50.0
In Commercial Distribution

  • 00815696021228 ()


  • Multiple coagulation factor IVD, control
George King Factor V Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor V donors.
GEORGE KING BIO-MEDICAL, INC
0500-200.0
In Commercial Distribution

  • 00815696021211 ()


  • Coagulation factor V IVD, reagent
George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived from non-medicated, non-smoking donors between the ages of 18 and 65 years of age. The kit is intended for use in establishing controlling reference ranges for coagulation assays.
GEORGE KING BIO-MEDICAL, INC
0075-20
In Commercial Distribution

  • 00815696021204 ()


  • Multiple coagulation factor IVD, control
George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged PT and.or aPTT.
GEORGE KING BIO-MEDICAL, INC
0010-500.0
In Commercial Distribution

  • 00815696021198 ()


  • Multiple coagulation factor IVD, control
George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor whohas developed an antibody to FVIII.
GEORGE KING BIO-MEDICAL, INC
1800-50
In Commercial Distribution

  • 00815696021181 ()


  • Coagulation factor VIII inhibitor IVD, control
George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII.
GEORGE KING BIO-MEDICAL, INC
1800-100
In Commercial Distribution

  • 00815696021174 ()


  • Coagulation factor VIII inhibitor IVD, control
George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII
GEORGE KING BIO-MEDICAL, INC
1800-250
In Commercial Distribution

  • 00815696021167 ()


  • Coagulation factor VIII inhibitor IVD, control
George King Factor XIII Deficient plasma is fresh frozen human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-250.0
In Commercial Distribution

  • 00815696021150 ()


  • Coagulation factor XIII A subunit IVD, control
George King Positive Lupus Anticoagulant is citrated fresh frozen human plasma derived from donors who have been diagnosed with the Anti-Phospholipid Antibody Syndrome (APS).
GEORGE KING BIO-MEDICAL, INC
5000-250.0
In Commercial Distribution

  • 00815696021143 ()


  • Lupus anticoagulant marker IVD, control
George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay.
GEORGE KING BIO-MEDICAL, INC
4000-330.0
In Commercial Distribution

  • 00815696021136 ()


  • Prothrombin time (PT) IVD, control
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