George King Pooled Normal Plasma

GUDID 00815696021297

George King Pooled Normal Plasma is fresh frozen citrated human plasma 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.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control
Primary Device ID00815696021297
NIH Device Record Key24cd1d03-773a-490b-9243-153b2e08ad6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeorge King Pooled Normal Plasma
Version Model Number0010-60.0
Company DUNS066761271
Company NameGEORGE KING BIO-MEDICAL, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com
Phone1-800-255-5108
Emailplasma@kingbiomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815696021297 [Primary]

FDA Product Code

GGNPlasma, Coagulation Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-11
Device Publish Date2022-03-03

On-Brand Devices [George King Pooled Normal Plasma]

00815696021044George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
00815696020542George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
00815696020535George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696020528George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696020290George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be us
00815696020283George King Pooled Normal Plasma is fresh frozen human citrated plasma and is intended to be use
00815696020276George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as
00815696020245George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696020139George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696020122George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696020115George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696020108George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
00815696021198George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
00815696021259George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
00815696021297George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.