GEORGE KING BIO-MEDICAL, INC

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Plasma, Coagulation Factor Deficient (GJT) (8) Control, Plasma, Abnormal (GGC) (1) Plasma, Coagulation Control (GGN) (1)

Premarket Exempt

No Yes

Clear

George King Factor IX Deficient Plasma - 00815696020009 Catalog Number :

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

Product Code : GJT

Prescription Use : Yes

Device Count : 1

George King Factor V Deficient Plasma - 00815696020023 Catalog Number :

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

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

George King Factor VIII Deficient Plasma - 00815696020030 Catalog Number :

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

George King Factor VIII Deficient Plasma - 00815696020047 Catalog Number :

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

George King Factor VII Deficient Plasma - 00815696020054 Catalog Number :

Device Description : George King Factor VII Deficient Plasma is fresh frozen citrated human plasma de George King Factor VII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VII Deficient donors

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

George King Factor X Deficient Plasma - 00815696020061 Catalog Number :

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

George King Factor XI Deficient Plasma - 00815696020078 Catalog Number :

Device Description : George King Factor XI Deficient Plasma is fresh frozen citrated human plasma der George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XI Deficient donors

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

George King Factor XII Deficient Plasma - 00815696020085 Catalog Number :

Device Description : George King Factor XII Deficient Plasma is fresh frozen citrated human plasma de George King Factor XII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor XII Deficient donors

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GJT

Prescription Use : Yes

Device Count : 1

George King Prekallikrein Deficient Plasma - 00815696020092 Catalog Number :

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

George King Pooled Normal Plasma - 00815696020108 Catalog Number :

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

Product Code : GGN

Prescription Use : Yes

Device Count : 1

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