FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740014575
Brand
ARCHITECT
Company
Abbott Ireland Diagnostics
Model
07K68-27
Catalog number
07K6827
Device description
ARCHTECT CEA Reagent kit
Published
2016-09-09
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
DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740014575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740014575003807400145753807400145750380740014575

GMDN Terms#

Term, Definition table
TermDefinition
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
985307301
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
00380740153953Alinity01R182101R18212019-01-04
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740168780Alinity04W022204W02222025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278620873MACGe Medical Systems Information Technologies, Inc.DHX2026-03-31
07613336218358Elecsys CEARoche Diagnostics GmbHDHX2025-11-07
10758750034307VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
20758750034304VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
00630414293585Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
00630414294131Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
04560189212244AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
14560189212241AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
00816870020532CEA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020549CEA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870020556CEA-NG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020563CEA-NG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022215CEA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022222CEA AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022239CEA-NG AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022246Monobind AccuLite CEA Next Generation CLIA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00380740130831AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130848AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130855AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130862AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00630414598505Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598536Atellica IM CEA MCMSiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598529Atellica IM CEA DILSiemens Healthcare Diagnostics Inc.DHX2017-12-27
00630414598512Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2017-12-22
04015630940370Elecsys Anti-CCPRoche Diagnostics GmbHDHX2017-04-21
04015630939664Elecsys CEARoche Diagnostics GmbHDHX2017-04-14
14560189210780ST AIA-PACK CEATOSOH CORPORATIONDHX2016-09-24
04560189211780AIA-PACK CEA Sample Diluting SolutionTOSOH CORPORATIONDHX2016-09-24
00842768019920Dimension Vista® Flex® reagent cartridge CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24
00630414126302ADVIA Centaur® CEA MCMSiemens Healthcare Diagnostics Inc.DHX2016-09-24