Home GUDID 00630414569277 ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents
Primary DI 00630414569277
Brand ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents
Company Siemens Healthcare Diagnostics Inc.
Model 10379635
Catalog number 10379635
Device description Ethanol - ADVIA Chem. - RGT - 4x150 tests
Published 2016-09-24
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 DML NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414569277 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 00630414569277 00630414569277 630414569277 0630414569277
GMDN Terms# Term, Definition table Term Definition Ethanol (ETOH) IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ethyl alcohol (ETOH) in a clinical specimen, using a spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not freeze, Avoid prolonged exposure to temperature above 32°C Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 064608573 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 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 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 00630414002873 ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator 10720859 10720859 2018-07-06 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00630414596112 Atellica CH ETOH Siemens Healthcare Diagnostics Inc. DML 2017-12-21 00842768002021 Syva® Emit® II Plus Ethyl Alcohol Assay Siemens Healthcare Diagnostics Inc. DML 2016-09-24 00842768002038 Syva® Emit® II Plus Ethyl Alcohol Assay Siemens Healthcare Diagnostics Inc. DML 2016-09-24 00842768014413 Syva® Emit® II Plus Ethyl Alcohol Assay Siemens Healthcare Diagnostics Inc. DML 2016-09-24 04015630927678 Ethanol Gen2 Roche Diagnostics GmbH DML 2016-09-20 04015630991761 Ethyl Alcohol ETH Roche Diagnostics GmbH DML 2016-09-20 04015630991778 Ethyl Alcohol ETH Roche Diagnostics GmbH DML 2016-09-20
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