Home GUDID 00711234170352 directCHECK ACT+ Whole Blood Control, Level 2
Primary DI 00711234170352
Brand directCHECK ACT+ Whole Blood Control, Level 2
Company ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model 000DCGACT-2
Catalog number 000DCGACT-2
Device description directCHECK GH100 ACT+L2 15/box
Published 2022-01-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 10711234170359 Primary GS1 0 00711234170352 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 10711234170359 10711234170359 00711234170352 00711234170352 711234170352 0711234170352
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 079299318 Device count 15 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 10711234170373 directCHECK ACT-LR Whole Blood Control, Level 2 000DCGLR-2 000DCGLR-2 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
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