Home GUDID 05056080501666 Thrombo-Wellcotest Glycine Saline
Primary DI 05056080501666
Brand Thrombo-Wellcotest Glycine Saline
Company REMEL EUROPE LIMITED
Model R30853101
Published 2021-07-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 05056080501666 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05056080501666 05056080501666 5056080501666
GMDN Terms# Term, Definition table Term Definition Evacuated blood collection tube IVD, no additive A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum with no additive. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations including trace elements, serology, and toxicology). This is a single-use device.
Regulatory Flags# DUNS number 232600853 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# 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 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 00630414986166 Stratus® CS Acute Care™ DDMR TestPak Siemens Healthcare Diagnostics Inc. DAP 2016-09-24
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