GEORGE KING BIO-MEDICAL, INC

Address:11771 WEST 112TH ST.,OVERLAND PARK,KS,66210,US

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Device Description : George King von Willebrand plasma, Type 1, is citrated human fresh frozen plasma George King von Willebrand plasma, Type 1, is citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 1. This plasma is intended for use as a control in the quantitative determination of von Willebrand Ag in citrated plasma.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGC

Prescription Use : Yes

Device Count : 1

Device Description : George King von Willebrand plasma, Type 2B, is citrated fresh frozen human plas George King von Willebrand plasma, Type 2B, is citrated fresh frozen human plasma derived from a donor diagnosed with vWD Type 2B. This plasma is intended for use as a control in the quantitative determination of von Willebrand Ag in citrated plasma.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGC

Prescription Use : Yes

Device Count : 1

Device Description : George King von Willebrand plasma, Type 3, is citrated human fresh frozen plasm George King von Willebrand plasma, Type 3, is citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 3. This plasma is intended for use as a control in the quantitative determination of von Willebrand in citrated plasma.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGC

Prescription Use : Yes

Device Count : 1

Device Description : George King Multi-Coumadin® Kit is citrated fresh frozen human plasma derived fr George King Multi-Coumadin® Kit 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Prekallikrein Deficient plasma is fresh frozen citrated human plasma George King Prekallikrein Deficient plasma is fresh frozen citrated human plasma derived from congenital Prekallikrein Deficient donors.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGC

Prescription Use : Yes

Device Count : 1

Device Description : George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGC

Prescription Use : Yes

Device Count : 1

Device Description : George King von Willebrand plasma, Type 3 is citrated human fresh frozen plasma George King von Willebrand plasma, Type 3 is citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 3. This plasma is intended for use as a control in the quantitative determination of von Willebrand Ag in citrated plasma.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGC

Prescription Use : Yes

Device Count : 1

Device Description : George King Factor X Deficient Plasma is fresh frozen citrated human plasma deri George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

Device Description : George King Factor X Deficient Plasma is fresh frozen citrated human plasma deri George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

Device Description : George King Factor X Deficient Plasma is fresh frozen citrated human plasma deri George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1