GEORGE KING BIO-MEDICAL, INC

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

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Device Description : George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Coumadin® Plasma is citrated fresh frozen human plasma derived from 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Single Donor Normal Plasma is fresh frozen citrated human plasma and 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Single Donor Normal Plasma is fresh frozen human citrated plasma and 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

Device Description : George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma d George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII 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 VIII Deficient Plasma is fresh frozen citrated human plasma d George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII 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 VIII Deficient Plasma is fresh frozen citrated human plasma d George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII 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 VIII Deficient Plasma is fresh frozen citrated human plasma d George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient donors.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1