Home GUDID 00630414002873 ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator
Primary DI 00630414002873
Brand ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator
Company Siemens Healthcare Diagnostics Inc.
Model 10720859
Catalog number 10720859
Device description ADVIA A1c_E Calibrator, 1x 3mL
Published 2018-07-06
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name JIT Calibrator, secondary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JIT Calibrator, Secondary Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414002873 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00630414002873 00630414002873 630414002873 0630414002873
GMDN Terms# Term, Definition table Term Definition Glycated haemoglobin (HbA1c) IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0
Regulatory Flags# DUNS number 064608573 Device count 1 DM exempt false Premarket exempt true 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 00630414465401 ADVIA® Chemistry CHE Cholinesterase Reagents 10329639 10329639 2020-09-24 00630414534794 ADVIA® 1800 Analyzer 10315183 10315183 2020-09-24 00630414000510 VERSANT HCV Control 2.0 Kit (LiPA) 10719668 10719668 2017-09-15 00630414454597 ADVIA Centaur® FOL 10331250 10331250 2016-09-24 00630414482309 ADVIA® 1650 Chemistry System Ref. 10309442 10309442 2018-12-01 00630414569277 ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents 10379635 10379635 2016-09-24 00630414580722 ADVIA Centaur® aTG MCM 10492692 10492692 2016-09-24 00630414602875 VERSANT HCV 2.0 LiPA 10492004 10492004 2017-09-15 00630414602882 VERSANT HCV 2.0 LiPA 10492005 10492005 2017-09-15 00630414008950 ADVIA Chemistry P5PL_c Reagent 10729782 10729782 2021-11-04 00630414508368 ADVIA® Chemistry ALT(GPT) Reagents 10309500 10309500 2020-09-24 00630414513157 ADVIA® Chemistry IRON_2 Reagents 10341118 10341118 2020-09-24 00630414553139 ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated 10283341 10283341 2020-09-24 00630414224923 ADVIA Cystatin C_2 Calibrator 10734510 10734510 2018-09-24 00630414517445 ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents 10341129 10341129 2016-09-24 00842768004872 Dimension® TACR Calibrator 10445012 10445012 2016-09-24 00842768018312 Dimension® Flex® reagent cartridge TACR 10444938 10444938 2016-09-24 00630414000497 VERSANT HCV 2.0 LiPA 10719666 10719666 2017-09-15 00630414000503 VERSANT HCV 2.0 LiPA 10719667 10719667 2017-09-15 00630414177021 ADVIA Centaur® TSH 10309958 10309958 2016-09-24
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