Home GUDID 10711234170373 directCHECK ACT-LR Whole Blood Control, Level 2
Primary DI 10711234170373
Brand directCHECK ACT-LR Whole Blood Control, Level 2
Company ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model 000DCGLR-2
Catalog number 000DCGLR-2
Device description directCHECK GH100 ACTLR2 15/box
Published 2022-01-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 10711234170373 Primary GS1 0 00711234170376 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10711234170373 10711234170373 00711234170376 00711234170376 711234170376 0711234170376
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 Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius Storage Environment Temperature 35 Degrees Fahrenheit 46 Degrees Fahrenheit
Regulatory Flags# DUNS number 079299318 Device count 15 DM 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 10711234170342 directCHECK ACT+ Whole Blood Control Level 1 000DCGACT-1 000DCGACT-1 2022-01-21 10711234170359 directCHECK ACT+ Whole Blood Control, Level 2 000DCGACT-2 000DCGACT-2 2022-01-21 10711234170366 directCHECK ACT-LR Whole Blood Controls, Level 1 000DCGLR-1 000DCGLR-1 2022-01-21 10711234101230 Hemochron Whole Blood Coagulation System PDAO PDAO 2016-09-22 10711234102176 Hemochron Whole Blood Coagulation System RQCHRT RQCHRT 2016-09-22 10711234102183 Hemochron Whole Blood Coagulation System RQCPRT RQCPRT 2016-09-22 10711234102206 Hemochron Whole Blood Coagulation System QCACT QCACT 2016-09-22 10711234107027 directCHECK Whole Blood Controls DCJAPTT-N DCJAPTT-N 2016-09-22 10711234107034 directCHECK Whole Blood Controls DCJAPTT-A DCJAPTT-A 2016-09-22 10711234107041 directCHECK Whole Blood Controls DCJPT-A DCJPT-A 2016-09-22 10711234107058 directCHECK Whole Blood Controls DCJACT-A DCJACT-A 2016-09-22 10711234107065 directCHECK Whole Blood Controls DCJCPT-A DCJCPT-A 2016-09-22 10711234107072 directCHECK Whole Blood Controls DCJCPT-N DCJCPT-N 2016-09-22 10711234107089 directCHECK Whole Blood Controls DCJLR-A DCJLR-A 2016-09-22 10711234107096 HepCheck Whole Blood Control DCP214-N DCP214-N 2016-09-22 10711234107102 HepCheck Whole Blood Control DCP214-A DCP214-A 2016-09-22 10711234170175 directCHECK Whole Blood Controls DCJCAPTT-A DCJCAPTT-A 2016-09-22 10711234170229 directCHECK Whole Blood Controls DCJACT-N DCJACT-N 2016-09-22 10711234170236 directCHECK Whole Blood Controls DCJPT-N DCJPT-N 2016-09-22 10711234170243 directCHECK Whole Blood Controls DCJLR-N DCJLR-N 2016-09-22
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