Home GUDID 10629009031050 VisuCon-F Low Fibrinogen Control Plasma
Primary DI 10629009031050
Brand VisuCon-F Low Fibrinogen Control Plasma
Company Affinity Biologicals Inc
Model LFGCP0105
Device description Assayed control plasma prepared from de-fibrinated human plasma intended for use in the quality control of quantitative fibrinogen assays in the low abnormal range.
Published 2017-04-28
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 16290090031058 Previous GS1 0 10629009031050 Primary GS1 0 10629009030015 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 16290090031058 16290090031058 10629009031050 10629009031050 10629009030015 10629009030015
GMDN Terms# Term, Definition table Term Definition Multiple coagulation marker 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 multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store at or below -60°C
Regulatory Flags# DUNS number 249373515 Device count 5 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 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 10629009121102 VisuCon-L(TM) Abnormal Control Plasma LYABP01 2019-10-22 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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