Home GUDID 00380740170141
ARCHITECT
Primary DI 00380740170141
Brand ARCHITECT
Company ABBOTT IRELAND
Model 09D9224
Catalog number 09D9224
Device description Apolipoprotein A1 243 Tests
Published 2023-08-10
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 DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740170141 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 00380740170141 00380740170141 380740170141 0380740170141
GMDN Terms# Term, Definition table Term Definition Apolipoprotein A-I (Apo A1) 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 quantitative measurement of apolipoprotein A-I (Apo A1) lipid in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 989964119 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 00380740170134 Alinity ABBOTT IRELAND DER 2021-05-19 00380740175139 ARCHITECT Abbott GmbH DER 2021-02-18 07613336133521 Tina-quant Apolipoprotein A-1 ver.2 Roche Diagnostics GmbH DER 2020-03-16 00380740153908 Alinity Abbott GmbH DER 2019-07-03 04015630917723 Tinaquant Apolipoprotein A1 ver2 Roche Diagnostics GmbH DER 2016-09-20 04015630917747 AI ver2 Tinaquant Apolipoprotein AI ver2 Roche Diagnostics GmbH DER 2016-09-20 04015630928651 Tinaquant Apolipoprotein A1 ver2 Roche Diagnostics GmbH DER 2016-09-20 04015630930227 Tinaquant Apolipoprotein AI ver2 Roche Diagnostics GmbH DER 2016-09-20 00816426020016 K-ASSAY® Apo AI Reagent KAMIYA BIOMEDICAL COMPANY, LLC DER 2016-09-16 00816426020030 K-ASSAY® Apo B Reagent KAMIYA BIOMEDICAL COMPANY, LLC DER 2016-09-16 00816426020177 K-ASSAY® Apo B Reagent (L) KAMIYA BIOMEDICAL COMPANY, LLC DER 2016-09-16 00817302020878 CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632 CAROLINA LIQUID CHEMISTRIES CORPORATION DER 2016-09-01 00817302020885 CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632 CAROLINA LIQUID CHEMISTRIES CORPORATION DER 2016-09-01 00817302020892 CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633 CAROLINA LIQUID CHEMISTRIES CORPORATION DER 2016-09-01 00817302020908 CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633 CAROLINA LIQUID CHEMISTRIES CORPORATION DER 2016-09-01 00817302020915 CAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633 CAROLINA LIQUID CHEMISTRIES CORPORATION DER 2016-09-01 00380740019716 ARCHITECT ABBOTT LABORATORIES DER 2016-06-06