Home GUDID 14987486015120 HEMOLYSIS WASHING SOLUTION 80H
Primary DI 14987486015120
Brand HEMOLYSIS WASHING SOLUTION 80H
Company ARKRAY USA, INC.
Model 103398
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
Published 2017-12-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
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 14987486015120 Package GS1 3 In Commercial Distribution 04987486015123 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14987486015120 14987486015120 04987486015123 04987486015123 4987486015123
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 Storage Environment Temperature 3 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 008171162 Device count 1 DM exempt false 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 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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