FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740169824
Brand
ARCHITECT
Company
Abbott GmbH
Model
08K4128
Catalog number
08K4128
Device description
ARCHITECT Insulin Reagent Kit
Published
2019-11-22
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
CFPRADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFPRadioimmunoassay, Immunoreactive InsulinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740169824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740169824003807401698243807401698240380740169824

GMDN Terms#

Term, Definition table
TermDefinition
Insulin IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of insulin in a clinical specimen, using a chemiluminescent immunoassay method.

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
Premarket exempt
true
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
00850049545723AccuDiag™ Insulin ELISADiagnostic Automation, Inc.CFP2026-01-27
00859410006269SalimetricsSALIMETRICS, LLCCFP2024-09-18
00859410006276SalimetricsSALIMETRICS, LLCCFP2024-09-18
04048474053616InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-09-01
04048474036084Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-31
04048474029352Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-29
00840239053619InsulinDRG International IncCFP2023-08-26
00840239036087Anti-Insulin ELISADRG International IncCFP2023-08-25
00840239029355Insulin ELISADRG International IncCFP2023-08-24
06925912718871iFlash-InsulinShenzhen YHLO Biotech Co., Ltd.CFP2022-10-26
00404847429350Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847436082Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847453614InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
B24280INSHUCH100STELLUX® Chemi Human Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE010ALPCO Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE100ALPCO Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE010ALPCO Ultrasensitive Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE100ALPCO Ultrasensitive Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
00630414461021ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466187ADVIA Centaur® IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466200ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600444Atellica IM IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600468Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600475Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414954028IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966014IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966045IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966243IMMULITE®/IMMULITE® 1000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414998954IMMULITE® INS Control InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
B24280INSHUCH010STELLUX® Chemi Human Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-07-17