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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The AMR von Willebrand Kit is a convenience kit that contains five levels of citrated human fresh frozen control material that can be used to verify the analytical measurement range of vWF Ag.
GEORGE KING BIO-MEDICAL, INC
0014-10
Not in Commercial Distribution

  • 00815696020474 ()


  • Coagulation factor VIII-associated antigen IVD, control
The AMR Coagulation Kit is a convenience kit that contains three levels of control material that can be used to verify the analytical measurement range of the eight different assays.
GEORGE KING BIO-MEDICAL, INC
0014-30
Not in Commercial Distribution

  • 00815696020467 ()


  • Multiple coagulation factor IVD, control
George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from donors who have been diagnosed with the Anti-Phospholipid Antibody Syndrome. (APS)
GEORGE KING BIO-MEDICAL, INC
5000-1.5
Not in Commercial Distribution

  • 00815696020450 ()


  • Lupus anticoagulant marker IVD, control
George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from donors who have been diagnosed with Anti-Phospholipid Antibody Syndrome (APS)
GEORGE KING BIO-MEDICAL, INC
5000-1.0
In Commercial Distribution

  • 00815696020443 ()


  • Lupus anticoagulant marker IVD, control
George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from donors who have been diagnosed with Anti-Phospholipid Antibody Syndrome (APS)
GEORGE KING BIO-MEDICAL, INC
5000-0.5
In Commercial Distribution

  • 00815696020436 ()


  • 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 - 1.5
Not in Commercial Distribution

  • 00815696020429 ()


  • Prothrombin time (PT) IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-50
In Commercial Distribution

  • 00815696020344 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-1.0
In Commercial Distribution

  • 00815696020337 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor XIII Deficient plasma is fresh frozen citrated human plasma derived from a congenital Factor XIII deficient donor.
GEORGE KING BIO-MEDICAL, INC
1300-0.5
In Commercial Distribution

  • 00815696020320 ()


  • Coagulation factor XIII A subunit IVD, control
George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient donors
GEORGE KING BIO-MEDICAL, INC
0800-2.0
In Commercial Distribution

  • 00815696020313 ()


  • Coagulation factor VIII IVD, reagent
George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors.
GEORGE KING BIO-MEDICAL, INC
0900-bulk
In Commercial Distribution

  • 00815696020306 ()


  • Coagulation factor IX IVD, reagent
George King Pooled Normal Plasma is fresh frozen citrated human 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
0010-250.0
In Commercial Distribution

  • 00815696020290 ()


  • Multiple coagulation factor IVD, control
George King Pooled Normal Plasma is fresh frozen human 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
0010-200.0
In Commercial Distribution

  • 00815696020283 ()


  • Multiple coagulation factor IVD, control
George King Pooled Normal Plasma is fresh frozen citrated human plasma 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
0010-100.0
In Commercial Distribution

  • 00815696020276 ()


  • Multiple coagulation factor IVD, control
George King Factor XII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XII Deficient donors.
GEORGE KING BIO-MEDICAL, INC
1200-bulk
In Commercial Distribution

  • 00815696020269 ()


  • Coagulation factor XII IVD, reagent
George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XI Deficient donors.
GEORGE KING BIO-MEDICAL, INC
1100-bulk
In Commercial Distribution

  • 00815696020252 ()


  • Coagulation factor XI IVD, reagent
George King Pooled Normal Plasma is fresh frozen citrated human 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
0010-50.0
In Commercial Distribution

  • 00815696020245 ()


  • Multiple coagulation factor IVD, control
George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors
GEORGE KING BIO-MEDICAL, INC
0900-100.0
In Commercial Distribution

  • 00815696020221 ()


  • Coagulation factor IX IVD, reagent
George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors
GEORGE KING BIO-MEDICAL, INC
0900-50.0
In Commercial Distribution

  • 00815696020214 ()


  • Coagulation factor IX IVD, reagent
George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient donors.
GEORGE KING BIO-MEDICAL, INC
0800-bulk
In Commercial Distribution

  • 00815696020207 ()


  • Coagulation factor VIII IVD, reagent
George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient donors
GEORGE KING BIO-MEDICAL, INC
0800-250.0
In Commercial Distribution

  • 00815696020191 ()


  • Coagulation factor VIII IVD, reagent
George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient donors
GEORGE KING BIO-MEDICAL, INC
0800-100.0
In Commercial Distribution

  • 00815696020184 ()


  • Coagulation factor VIII IVD, reagent
George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient donors
GEORGE KING BIO-MEDICAL, INC
0800-50.0
In Commercial Distribution

  • 00815696020177 ()


  • Coagulation factor VIII IVD, reagent
George King Single Donor Normal Plasma is fresh frozen human citrated 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-bulk
In Commercial Distribution

  • 00815696020160 ()


  • Multiple coagulation factor IVD, control
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
0001-1.0
In Commercial Distribution

  • 00815696020153 ()


  • Multiple coagulation factor 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 - 1.0
In Commercial Distribution

  • 00815696020146 ()


  • Prothrombin time (PT) IVD, control
George King Pooled Normal Plasma is fresh frozen citrated human 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
0010-5.0
In Commercial Distribution

  • 00815696020139 ()


  • Multiple coagulation factor IVD, control
George King Pooled Normal Plasma is fresh frozen citrated human 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
0010-1.5
In Commercial Distribution

  • 00815696020122 ()


  • Multiple coagulation factor IVD, control
George King Pooled Normal Plasma is fresh frozen citrated human 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
0010-0.5
In Commercial Distribution

  • 00815696020115 ()


  • 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
0010-1.0
In Commercial Distribution

  • 00815696020108 ()
  • 10815696020105 ()
  • 20815696020102 ()
  • 30815696020109 ()


  • Multiple coagulation factor IVD, control
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