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
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