FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740019716
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
9D92-21
Catalog number
09D9221
Device description
Apolipoprotein A1
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DERALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DERAlpha-1-Lipoprotein, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740019716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740019716003807400197163807400197160380740019716

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein A-I (Apo A1) IVD, reagentA 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
TypeLowHighCondition
Handling Environment Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170141ARCHITECTABBOTT IRELANDDER2023-08-10
00380740170134AlinityABBOTT IRELANDDER2021-05-19
00380740175139ARCHITECTAbbott GmbHDER2021-02-18
07613336133521Tina-quant Apolipoprotein A-1 ver.2Roche Diagnostics GmbHDER2020-03-16
00380740153908AlinityAbbott GmbHDER2019-07-03
04015630917723Tinaquant Apolipoprotein A1 ver2Roche Diagnostics GmbHDER2016-09-20
04015630917747AI ver2 Tinaquant Apolipoprotein AI ver2Roche Diagnostics GmbHDER2016-09-20
04015630928651Tinaquant Apolipoprotein A1 ver2Roche Diagnostics GmbHDER2016-09-20
04015630930227Tinaquant Apolipoprotein AI ver2Roche Diagnostics GmbHDER2016-09-20
00816426020016K-ASSAY® Apo AI ReagentKAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00816426020030K-ASSAY® Apo B ReagentKAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00816426020177K-ASSAY® Apo B Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00817302020878CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020885CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020892CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020908CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020915CAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01