Home GUDID 04987486015130 DILUENT 80
Primary DI 04987486015130
Brand DILUENT 80
Company ARKRAY USA, INC.
Model 103399
Device description These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes commercially available freeze-dried controls and dilutes white blood samples.
Published 2018-02-08
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 PDJ Hemoglobin A1c Test System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PDJ Hemoglobin A1c Test System Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04987486015130 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04987486015130 04987486015130 4987486015130
GMDN Terms# Term, Definition table Term Definition Glycated haemoglobin (HbA1c) IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Opened: Store in a refrigerator (2-8C) Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 008171162 Device count 1 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 04987486009801 AUTION Check Plus Controls 102478 2020-02-26 04987486001959 S.G. Calibrator H 100672 2017-04-12 04987486053002 S.G. Calibrator H 111581 N/A 2025-12-19 00015482104658 AUTION MAX™ AX-4060 Analyzer 100526 2025-11-07 00015482510060 Assure® Control - Control Solution Level 2 & Level 3 510006 2025-09-26 00015482600501 Assure® Titanium Blood Glucose Test Strips 600050 2025-09-15 00015482601003 Assure® Titanium Blood Glucose Test Strips 600100 2025-09-15 00015482600013 Assure® Titanium Blood Glucose Meter 600001 2025-09-15 10015482600508 Assure® Titanium Blood Glucose Test Strips 600050 2025-09-15 10015482601000 Assure® Titanium Blood Glucose Test Strips 600100 2025-09-15 00015482510046 Assure® Control - Control Solution Level 1 510004 2019-04-01 00015482510053 Assure® Control - Control Solution Level 2 510005 2019-04-01 00015482510077 Assure® Control - Control Solution Level 3 510007 2019-04-01 00015482102913 ASSURE® ID Insulin 1cc Safety Syringe 210291 2016-09-23 00015482102951 ASSURE® ID Insulin 0.5cc Safety Syringe 210295 2016-09-23 00015482511104 GLUCOCARD® W Blood Glucose Monitoring System 511100 2019-04-01 00015482512057 GLUCOCARD® W Blood Glucose Test Strips 512050 2019-04-01 10015482102910 ASSURE® ID Insulin 1cc Safety Syringe 210291 2016-09-23 10015482102958 ASSURE® ID Insulin 0.5cc Safety Syringe 210295 2016-09-23 30015482501779 Assure® Platinum Blood Glucose Meter 501177 2022-06-17
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