Home GUDID 10758750005048 VITROS
Primary DI 10758750005048
Brand VITROS
Company ORTHO-CLINICAL DIAGNOSTICS, INC.
Model 8578163
Catalog number 8578163
Device description VITROS Chemistry Products Calibrator Kit 8
Published 2016-08-23
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 DNN CALIBRATORS, ETHYL ALCOHOL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DNN Calibrators, Ethyl Alcohol Clinical Toxicology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10758750005048 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10758750005048 10758750005048
GMDN Terms# Term, Definition table Term Definition Ethanol (ETOH) IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not freeze Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 623873044 Device count 1 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 00811727017413 Pointe Ethyl Alcohol Calibrator (100 mg/dL) HORIBA INSTRUMENTS INCORPORATED DNN 2020-09-25 04250317536754 Urine Calibrator Set Chromsystems Instruments + Chemicals GmbH DNN 2019-03-22 00380740135355 Alinity ABBOTT LABORATORIES DNN 2018-07-11 00852553007247 Ethanol Standard Kit VERICHEM LABORATORIES, INC. DNN 2018-01-16 00852553007346 Ethanol Standard, Level D VERICHEM LABORATORIES, INC. DNN 2018-01-16 00884883005129 DRI Negative Alcohol Calibrator Microgenics Corporation DNN 2016-09-12 00884883005198 DRI 100 mg/dL Alcohol Calibrator Microgenics Corporation DNN 2016-09-12 00884883011540 DRI 100 mg/dL Alcohol Calibrator Microgenics Corporation DNN 2016-09-12 00884883011564 DRI Negative Alcohol Calibrator Microgenics Corporation DNN 2016-09-12 00817302021332 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT MR421 CAROLINA LIQUID CHEMISTRIES CORPORATION DNN 2016-09-01 00817302021349 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT BL-421 CAROLINA LIQUID CHEMISTRIES CORPORATION DNN 2016-09-01 00817302021356 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST421 CAROLINA LIQUID CHEMISTRIES CORPORATION DNN 2016-09-01 00817302021363 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT ST321 CAROLINA LIQUID CHEMISTRIES CORPORATION DNN 2016-09-01 00817302021370 CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421 CAROLINA LIQUID CHEMISTRIES CORPORATION DNN 2016-09-01 00817302021387 CAROLINA LIQUID CHEMISTRIES CORP.® ETHYL ALCOHOL CC421 CAROLINA LIQUID CHEMISTRIES CORPORATION DNN 2016-09-01 00811727010087 POINTE SCIENTIFIC Alcohol Standard HORIBA INSTRUMENTS INCORPORATED DNN 2016-08-31 15099590222079 Synchron Beckman Coulter, Inc. DNN 2016-08-24 B07602230 Ethyl Alcohol DAU Calibrator, Calibrator #2 LIN-ZHI INTERNATIONAL, INC. DNN 2016-07-05 00380740005511 ARCHITECT ABBOTT LABORATORIES DNN 2016-06-06 00380740005528 ARCHITECT ABBOTT LABORATORIES DNN 2016-06-06 00380740005535 ARCHITECT ABBOTT LABORATORIES DNN 2016-06-06 00380740005542 ARCHITECT ABBOTT LABORATORIES DNN 2016-06-06