Home GUDID 00380740135379 Alinity
Primary DI 00380740135379
Brand Alinity
Company ABBOTT LABORATORIES
Model 08P4110
Catalog number 08P4110
Device description Alinity c Ethanol Control Kit
Published 2018-07-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DKC Alcohol control materials
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DKC Alcohol Control Materials Clinical Toxicology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740135379 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 00380740135379 00380740135379 380740135379 0380740135379
GMDN Terms# Term, Definition table Term Definition Ethanol (ETOH) IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme 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 Handling Environment Humidity 0 Percent (%) Relative Humidity 0 Percent (%) Relative Humidity Handling Environment Temperature 0 30 Degrees Celsius Storage Environment Humidity 0 Percent (%) Relative Humidity 0 Percent (%) Relative Humidity Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 079226220 Device count 1 Premarket exempt true Kit 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 00811727017420 Pointe Ethyl Alcohol Level 1 Control (50 mg/dL) HORIBA INSTRUMENTS INCORPORATED DKC 2020-09-25 00811727017437 Pointe Ethyl Alcohol Level 2 Control (300 mg/dL) HORIBA INSTRUMENTS INCORPORATED DKC 2020-09-25 04250317544742 Urine Control Chromsystems Instruments + Chemicals GmbH DKC 2020-08-06 04250317546067 Urine Control Chromsystems Instruments + Chemicals GmbH DKC 2020-08-06 04250317546111 Urine Control Chromsystems Instruments + Chemicals GmbH DKC 2020-08-06 04250317535771 Urine Control Chromsystems Instruments + Chemicals GmbH DKC 2020-08-06 04250317535788 Urine Control Chromsystems Instruments + Chemicals GmbH DKC 2020-08-06 04250317535795 Urine Control Chromsystems Instruments + Chemicals GmbH DKC 2020-08-06 04250317544971 Serum Control Chromsystems Instruments + Chemicals GmbH DKC 2020-07-30 04250317545213 Serum Control Chromsystems Instruments + Chemicals GmbH DKC 2020-07-30 04250317502209 Serum Control Chromsystems Instruments + Chemicals GmbH DKC 2020-07-30 04250317502223 Serum Control Chromsystems Instruments + Chemicals GmbH DKC 2020-07-30 00817238011568 WHOLE BLOOD ETHANOL CONTROL LEVEL1 CLINIQA CORPORATION DKC 2018-08-23 00817238011575 WHOLE BLOOD ETHANOL CONTROL LEVEL 2 CLINIQA CORPORATION DKC 2018-08-23 00884883001015 DRI 50 mg/dL Alcohol Control Microgenics Corporation DKC 2017-10-30 00884883001039 DRI 300 mg/dL Alcohol Control Microgenics Corporation DKC 2017-10-30 00840937110683 Immunalysis IMMUNALYSIS CORP DKC 2017-10-24 00840937110409 Immunalysis IMMUNALYSIS CORP DKC 2017-09-07 00884883005129 DRI Negative Alcohol Calibrator Microgenics Corporation DKC 2016-09-12 00884883005198 DRI 100 mg/dL Alcohol Calibrator Microgenics Corporation DKC 2016-09-12 00884883011540 DRI 100 mg/dL Alcohol Calibrator Microgenics Corporation DKC 2016-09-12 00884883011564 DRI Negative Alcohol Calibrator Microgenics Corporation DKC 2016-09-12 00817302021332 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 CAROLINA LIQUID CHEMISTRIES CORPORATION DKC 2016-09-01 00817302021349 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 CAROLINA LIQUID CHEMISTRIES CORPORATION DKC 2016-09-01 00817302021356 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 CAROLINA LIQUID CHEMISTRIES CORPORATION DKC 2016-09-01 00817302021363 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 CAROLINA LIQUID CHEMISTRIES CORPORATION DKC 2016-09-01 00817302021370 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 CAROLINA LIQUID CHEMISTRIES CORPORATION DKC 2016-09-01 00817302021387 CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 CAROLINA LIQUID CHEMISTRIES CORPORATION DKC 2016-09-01 15099590222710 Synchron Beckman Coulter, Inc. DKC 2016-08-24 15099590222727 Synchron Beckman Coulter, Inc. DKC 2016-08-24
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