Address:11771 WEST 112TH ST.,OVERLAND PARK,KS,66210,US
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
Prescription Use : Yes
Device Description : George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended 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.
Device Class : 2
Duns Number: 066761271
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : George King Single Donor Normal Plasma is fresh frozen citrared human plasma and George King Single Donor Normal Plasma is fresh frozen citrared 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
Prescription Use : Yes
Device Description : George King FACT is a normal fresh frozen citrated control that is used to verif George King FACT is a normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.
Device Class : 2
Duns Number: 066761271
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : George King B-FACT is a borderline normal fresh frozen citrated control that is George King B-FACT is a borderline normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.
Device Class : 2
Duns Number: 066761271
Premarket Exempt : No
Prescription Use : Yes
Device Description : George King A-FACT is a low abnormal fresh frozen citrated control that is used George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.
Device Class : 2
Duns Number: 066761271
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes
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
Prescription Use : Yes
Device Description : George King Factor IX Deficient Plasma is fresh frozen citrated human plasma der George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors
Device Class : 2
Duns Number: 066761271
Premarket Exempt : Yes
Prescription Use : Yes
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
Prescription Use : Yes