FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740175139
Brand
ARCHITECT
Company
Abbott GmbH
Model
9D92-22
Catalog number
09D9222
Device description
Apolipoprotein A1
Published
2021-02-18
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
00380740175139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740175139003807401751393807401751390380740175139

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
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
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740170141ARCHITECTABBOTT IRELANDDER2023-08-10
00380740170134AlinityABBOTT IRELANDDER2021-05-19
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
00380740019716ARCHITECTABBOTT LABORATORIESDER2016-06-06