Home GUDID 10711234540046 directCHECK Whole Blood Controls
Primary DI 10711234540046
Brand directCHECK Whole Blood Controls
Company ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model DCJ-005
Catalog number DCJ-005
Device description Protective Sleeves
Published 2016-09-22
Public version status Update
Distribution status 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 10711234540046 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10711234540046 10711234540046
GMDN Terms# Term, Definition table Term Definition Coagulation analyser IVD, point-of-care, line-powered A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used exclusively at the point-of-care by medical professionals for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. It may include spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.
Regulatory Flags# DUNS number 079299318 Device count 1 DM exempt true Lot or batch 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 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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