FDA.reportPublic FDA data

Elecsys CA 15-3 II

Primary DI
04015630939961
Brand
Elecsys CA 15-3 II
Company
Roche Diagnostics GmbH
Model
07027001190
Catalog number
07027001190
Published
2018-03-15
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
MOISYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171605000
K181492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171605000Elecsys CA 15-3 IIRoche Diagnostics2018-02-20MOI
K181492000Elecsys CA 15-3 IIRoche Diagnostics2018-06-22MOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630939961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630939961040156309399614015630939961

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.

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
14560189212081ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
04560189210172ST AIA-PACK 27.29TOSOH CORPORATIONMOI2026-02-02
07613336218334Elecsys CA 15-3 IIRoche Diagnostics GmbHMOI2024-07-30
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
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