Home GUDID 10629009084810 VisuCon-F Frozen Coag Screen ABN
Primary DI 10629009084810
Brand VisuCon-F Frozen Coag Screen ABN
Company Affinity Biologicals Inc
Model FCSAB0481
Device description Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) in the mid-level 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 16290090084818 Previous GS1 0 10629009084810 Primary GS1 0 10629009080041 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 16290090084818 16290090084818 10629009084810 10629009084810 10629009080041 10629009080041
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 81 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 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
Other Devices Sharing Product Codes# 
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