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

Control, Plasma, Abnormal (GGC) (7) Plasma, Coagulation Control (GGN) (7)

Premarket Exempt

No Yes

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George King Positive Lupus Anticoagulant - 00815696020436 Catalog Number :

Device Description : George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma d George King Positive Lupus Anticoagulant is fresh frozen citrated human plasma derived from donors who have been diagnosed with Anti-Phospholipid Antibody Syndrome (APS)

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGC

Prescription Use : Yes

Device Count : 1

George King Positive Lupus Anticoagulant - 00815696020443 Catalog Number :

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGC

Prescription Use : Yes

Device Count : 1

George King Positive Lupus Anticoagulant - 00815696020450 Catalog Number :

Device Description : George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma d 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)

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGC

Prescription Use : Yes

Device Count : 1

George King AMR Coagulation Kit - 00815696020467 Catalog Number :

Device Description : The AMR Coagulation Kit is a convenience kit that contains three levels of contr 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : Yes

Device Count : 1

George King AMR von Willebrand Kit - 00815696020474 Catalog Number :

Device Description : The AMR von Willebrand Kit is a convenience kit that contains five levels of cit 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.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : Yes

Device Count : 1

George King SysCOR Kit - 00815696020481 Catalog Number :

Device Description : SysCOR is a System Control convenience kit which contains different levels of co SysCOR is a System Control convenience kit which contains different levels of control material that can be used to correlate results when changing lot numbers of reagents and/or instrument platforms.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : Yes

Device Count : 1

George King SysCOR Plus Kit - 00815696020498 Catalog Number :

Device Description : SysCOR Plus is a System Control convenience kit which contains different levels SysCOR Plus is a System Control convenience kit which contains different levels of control material that can be used to correlate results when changing lot numbers of reagents and/or instrument platforms. Similar to the SysCOR kit but with five additional Coumadin® control plasmas.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : No

Product Code : GGN, GGC

Prescription Use : Yes

Device Count : 1

George King CORE Kit - 00815696020504 Catalog Number :

Device Description : George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated huma George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived from non-mediated, non-smoking donors between the ages of 18-56 years of age. The kit contains 15 males and 15 females and is intended for use in establishing reference ranges for coagulation assays.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

George King CORE Kit - 00815696020511 Catalog Number :

Device Description : George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated huma George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived from non-mediated, non-smoking donors between the ages of 18-56 years of age. The kit contains 25 males and 25 females and is intended for use in establishing reference ranges for coagulation assays.

Device Class : 2

Duns Number: 066761271

Premarket Exempt : Yes

Product Code : GGN

Prescription Use : Yes

Device Count : 1

George King Pooled Normal Plasma - 00815696020528 Catalog Number :

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

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