FDA.reportPublic FDA data

Elecsys CA 125 II

Primary DI
04015630939633
Brand
Elecsys CA 125 II
Company
Roche Diagnostics GmbH
Model
07026986190
Catalog number
07026986190
Published
2017-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K143534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143534000Elecsys CA-125 II assayRoche Professional Diagnostics2015-08-06LTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630939633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630939633040156309396334015630939633

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

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

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
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
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