FDA.reportPublic FDA data

Elecsys CA 15-3 II

Primary DI
07613336218334
Brand
Elecsys CA 15-3 II
Company
Roche Diagnostics GmbH
Model
09755594190
Catalog number
09755594190
Published
2024-07-30
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
MOISystem, test, immunological, antigen, tumor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOISystem, Test, Immunological, Antigen, TumorImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181492000Elecsys CA 15-3 IIRoche Diagnostics2018-06-22MOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336218334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336218334076133362183347613336218334

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

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
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14560189212081ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
04560189210172ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
00630414293479Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414293486Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414293509Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294049Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294056Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2020-05-31
00630414294063Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2020-05-31
00816870020495Monobind AccuBind CA 15-3 ELISA Kit - 96 WellsMONOBIND, INC.MOI2019-02-11
00816870020501CA 15-3 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.MOI2019-02-11
00816870022178CA 15-3 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.MOI2019-02-11
00816870022185CA 15-3 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MOI2019-02-11
00380740145316ARCHITECTAbbott GmbHMOI2019-01-21
00380740145323ARCHITECTAbbott GmbHMOI2019-01-21
00380740145330ARCHITECTAbbott GmbHMOI2019-01-21
00380740131432AlinityAbbott GmbHMOI2018-12-31
00380740131449AlinityAbbott GmbHMOI2018-12-31
04015630939961Elecsys CA 15-3 IIRoche Diagnostics GmbHMOI2018-03-15
00630414598055Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598123Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598130Atellica IM CA 15-3Siemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598154Atellica IM CA 15-3 MCMSiemens Healthcare Diagnostics Inc.MOI2018-02-06
00630414598048Atellica IM BRSiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598062Atellica IM BR MCMSiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598079Atellica IM BR PRESiemens Healthcare Diagnostics Inc.MOI2017-12-27
00630414598147Atellica IM CA 15-3® CalibratorSiemens Healthcare Diagnostics Inc.MOI2017-12-22
00630414598420Atellica IM BR CalibratorSiemens Healthcare Diagnostics Inc.MOI2017-12-22
04251269200144Pin Type Socket WrenchNoras MRI products GmbHMOI2017-09-13
04251269200595Head Holder FlexibilityNoras MRI products GmbHMOI2017-09-06
04251269200601Back Cushion Flexibility MaquetNoras MRI products GmbHMOI2017-09-06