Home GUDID 10629009121102 VisuCon-L(TM) Abnormal Control Plasma
Primary DI 10629009121102
Brand VisuCon-L(TM) Abnormal Control Plasma
Company Affinity Biologicals Inc
Model LYABP01
Device description A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.
Published 2019-10-22
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name GGN Plasma, Coagulation Control
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GGN Plasma, Coagulation Control Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10629009121102 Primary GS1 0 10629009120013 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10629009121102 10629009121102 10629009120013 10629009120013
GMDN Terms# Term, Definition table Term Definition Multiple coagulation factor IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 249373515 Device count 10 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10629009031050 VisuCon-F Low Fibrinogen Control Plasma LFGCP0105 2017-04-28 10629009031258 VisuCon-F Low Fibrinogen Control Plasma LFGCP0125 2017-04-28 10629009031814 VisuCon-F Low Fibrinogen Control Plasma LFGCP0181 2017-04-28 10629009041059 Visu-Cal F Frozen Calibrator Plasma FRSP0105 2017-04-28 10629009041257 VisuCal-F Frozen Calibrator Plasma FRSP0125 2017-04-28 10629009051058 VisuCon-F Frozen Calibrator Plasma FRNCP0105 2017-04-28 10629009051256 VisuCon-F Frozen Normal Control Plasma FRNCP0125 2017-04-28 10629009061057 VisuCon-F Frozen Abnormal Control Plasma FRABP0105 2017-04-28 10629009061255 VisuCon-F Frozen Abnormal Control Plasma FRABP0125 2017-04-28 10629009071254 VisuCon-F Frozen Coag Screen N FCSN0125 2017-04-28 10629009071810 VisuCon-F Frozen Coag Screen N FCSN0181 2017-04-28 10629009074811 VisuCon-F Frozen Coag Screen N FCSN0481 2017-04-28 10629009081253 VisuCon-F Frozen Coag Screen ABN FCSAB0125 2017-04-28 10629009081819 VisuCon-F Frozen Coag Screen ABN FCSAB0181 2017-04-28 10629009084810 VisuCon-F Frozen Coag Screen ABN FCSAB0481 2017-04-28 10629009091108 VisuCon-L Coag Screen N Plasma LSCN01 2018-10-19 10629009101104 VisuCon-L Coag Screen ABN1 Plasma LCSAB101 2018-10-19 10629009111103 VisuCon-L Coag Screen ABN2 Plasma LCSAB201 2018-10-19 10629009131101 VisuCon-L(TM) Normal Control Plasma LYNCP01 2019-10-22 10629009140516 Sheep anti-human Factor XIII Analyte Specific Reagent SAFXIII-IG-ASR-5 2022-09-23
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