Home GUDID 08426950485605 HemosIL D-Dimer HS 500
Primary DI 08426950485605
Brand HemosIL D-Dimer HS 500
Company INSTRUMENTATION LABORATORY COMPANY
Model 00020500100
Catalog number 00020500100
Device description HemosIL D-Dimer HS 500
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DAP FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08426950485605 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08426950485605 08426950485605 8426950485605
GMDN Terms# Term, Definition table Term Definition D-dimer IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen, using an agglutination method.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Unopened reagents and calibrator are stable until the expiration date shown on the vial when stored at 2-8°C. Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 557223252 Device count 1 Kit 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 08426950071068 HemosIL Normal Control ASSAYED 00020003110 00020003110 2016-09-23 08426950088646 GEM Check Coag Control-Abnormal for ACT-LR 06260060200 06260060200 2016-09-23 08426950088653 GEM Check Coag Control-Abnormal for ACT 06260060300 06260060300 2016-09-23 08426950452683 GEM Check Coag Control-Normal for Citrate PT 06260061100 06260061100 2016-09-23 08426950452713 GEM Check Coag Control-Abnormal for Citrate PT 06260061400 06260061400 2016-09-23 08426950452744 GEM Check Coag Control-Normal for ACT 06260060500 06260060500 2016-09-23 08426950452751 GEM Check Coag Control-Normal for ACT-LR 06260060600 06260060600 2016-09-23 08426950573401 HemosIL Routine Control Level 3 00020005800 00020005800 2016-09-23 08426950660668 HemosIL Abnormal Control 2 00020014000 00020014000 2016-09-23 08426950078982 HemosIL Low Abnormal Control ASSAYED 00020003210 00020003210 2016-09-23 08426950078999 HemosIL High Abnormal Control ASSAYED 00020003310 00020003310 2016-09-23 08426950087595 HemosIL Calibration Plasma 00020003700 00020003700 2016-09-23 08426950088639 GEM Check Coag Control-Abnormal for APTT 06260060100 06260060100 2016-09-23 08426950088912 Coatest APCR Control Plasma Level 1 82 2650 63 82 2650 63 2016-09-23 08426950088929 Coatest APCR Control Plasma Level 2 82 2668 63 82 2668 63 2016-09-23 08426950442189 HemosIL Special Test Control Level 2 00020012000 00020012000 2016-09-23 08426950452690 GEM Check Coag Control-Normal for APTT 06260061600 06260061600 2016-09-23 08426950452706 GEM Check Coag Control-Abnormal for PT 06260061700 06260061700 2016-09-23 08426950452737 GEM Check Coag Control-Normal for PT 06260060400 06260060400 2016-09-23 08426950453062 HemosIL Special Test Control Level 1 00020011000 00020011000 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816870023878 D-Dimer AccuLite CLIA Test System - 192 Wells MONOBIND, INC. DAP 2024-09-13 00816870023885 D-Dimer AccuLite CLIA Test System - 96 Wells MONOBIND, INC. DAP 2024-09-13 00816870023892 D-Dimer AccuBind ELISA Test System - 192 Wells MONOBIND, INC. DAP 2024-09-13 00816870023908 D-Dimer AccuBind ELISA Test System - 96 Wells MONOBIND, INC. DAP 2024-09-13 00630414639666 INNOVANCE® D-Dimer Sample Diluent Siemens Healthcare Diagnostics Products GmbH DAP 2024-03-25 00842768019265 INNOVANCE® D-Dimer Sample Diluent Siemens Healthcare Diagnostics Products GmbH DAP 2024-03-25 00630414640181 INNOVANCE D-Dimer Controls Siemens Healthcare Diagnostics Products GmbH DAP 2024-03-25 00630414640488 INNOVANCE D-Dimer Siemens Healthcare Diagnostics Products GmbH DAP 2024-03-25 00630414640501 INNOVANCE D-Dimer Siemens Healthcare Diagnostics Products GmbH DAP 2024-03-25 05056080501666 Thrombo-Wellcotest Glycine Saline REMEL EUROPE LIMITED DAP 2021-07-21 08426951391615 HemosIL D-Dimer HS 500 INSTRUMENTATION LABORATORY COMPANY DAP 2019-06-10 00895160002502 Fluoro-CheckTM D-Dimer NANO-DITECH CORPORATION DAP 2019-05-24 30014613337959 Triage QUIDEL CARDIOVASCULAR INC. DAP 2018-11-01 30014613338000 Triage QUIDEL CARDIOVASCULAR INC. DAP 2018-11-01 30014613338017 Triage QUIDEL CARDIOVASCULAR INC. DAP 2018-11-01 00817089020542 Diazyme DIAZYME LABORATORIES, INC. DAP 2016-11-03 00893038002326 Alere Triage® Alere San Diego, Inc. DAP 2016-09-26 00899722002733 Alere Triage® Alere San Diego, Inc. DAP 2016-09-26 00899722002740 Alere Triage® Alere San Diego, Inc. DAP 2016-09-26 B1761070 Antiserum to Human Fibrinogen KENT LABORATORIES INC DAP 2016-09-24 05056080500041 NA REMEL EUROPE LIMITED DAP 2016-09-24 05056080500058 NA REMEL EUROPE LIMITED DAP 2016-09-24 00842768003967 Dade® DIMERTEST® Latex Assay Siemens Healthcare Diagnostics Products GmbH DAP 2016-09-24 00842768003974 Dade® DIMERTEST® Latex Beads Siemens Healthcare Diagnostics Products GmbH DAP 2016-09-24 00842768004575 Acute Care™ D-DIMER CalPak Siemens Healthcare Diagnostics Inc. DAP 2016-09-24 00842768004582 Stratus® CS Acute Care™ DDMR DilPak Siemens Healthcare Diagnostics Inc. DAP 2016-09-24 00842768022814 INNOVANCE® D-Dimer Siemens Healthcare Diagnostics Products GmbH DAP 2016-09-24 00842768022821 INNOVANCE® D-Dimer Siemens Healthcare Diagnostics Products GmbH DAP 2016-09-24 00842768023668 INNOVANCE® D-Dimer Controls Siemens Healthcare Diagnostics Products GmbH DAP 2016-09-24 00842768027611 INNOVANCE® D-Dimer Sample Diluent Siemens Healthcare Diagnostics Products GmbH DAP 2016-09-24
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