FDA.reportPublic FDA data

VITROS

Primary DI
10758750034901
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6177751
Catalog number
6177751
Device description
VITROS Immunodiagnostic Products CA 125 II Calibrators
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K221355000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221355000VITROS Immuodiagnostic Products CA 125 II Reagent PackOrtho Clinical Diagnostics2022-12-12LTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750034901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875003490110758750034901

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 Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
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
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

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
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
00380740145361ARCHITECTAbbott GmbHLTK2019-01-21
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