FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740145361
Brand
ARCHITECT
Company
Abbott GmbH
Model
02K4524
Catalog number
02K4524
Device description
ARCHITECT CA 125 II Reagent Kit
Published
2019-01-21
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
LTKTEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042731000ARCHITECT CA 125 II ASSAYFujirebio Diagnostics,Inc.2004-11-19LTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740145361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740145361003807401453613807401453610380740145361

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
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
07613336218327Elecsys CA 125 IIRoche Diagnostics GmbHLTK2024-08-13
10758750034826VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
10758750034901VITROSORTHO CLINICAL DIAGNOSTICSLTK2023-03-14
00630414293493Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2020-05-31
00630414294278Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2020-05-31
00380740131043AlinityAbbott GmbHLTK2019-02-12
00816870020471CA-125 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870020488CA-125 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTK2019-02-11
00816870022154CA-125 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTK2019-02-11
00816870022161CA-125 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTK2019-02-11
00380740145378ARCHITECTAbbott GmbHLTK2019-01-21
00380740145385ARCHITECTAbbott GmbHLTK2019-01-21
00380740131050AlinityAbbott GmbHLTK2018-12-31
00630414598116Atellica IM CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2017-12-27
00630414598086Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598093Atellica IM CA 125IISiemens Healthcare Diagnostics Inc.LTK2017-12-22
00630414598109Atellica IM CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2017-12-22
04015630939633Elecsys CA 125 IIRoche Diagnostics GmbHLTK2017-04-14
14560189210216ST AIA-PACK CA 125TOSOH CORPORATIONLTK2016-09-24
04560189211131AIA-PACK CA 125 Sample Diluting SolutionTOSOH CORPORATIONLTK2016-09-24
04560189211148AIA-PACK CA 125 Calibrator SetTOSOH CORPORATIONLTK2016-09-24
00842768028519Dimension Vista® Flex® reagent cartridge CA125Siemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461274ADVIA Centaur® CA 125II MCMSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461298ADVIA Centaur® CA 125IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461304ADVIA Centaur® CA 125 IISiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414461335ADVIA Centaur® Systems CA 125II CalibratorSiemens Healthcare Diagnostics Inc.LTK2016-09-24
00630414954127IMMULITE®/IMMULITE® 1000 Systems OMM OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954134IMMULITE® 2000 Systems OM-MA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414954219IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24
00630414961798IMMULITE® 2000 Systems OV OM-MA (CA125)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLTK2016-09-24