FDA.reportPublic FDA data

Atellica IM CA 15-3

Primary DI
00630414294063
Brand
Atellica IM CA 15-3
Company
Siemens Healthcare Diagnostics Inc.
Model
11206238
Catalog number
11206238
Device description
CA 15-3 Atellica IM - RGT 500T
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K012357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012357000CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEMBayer Diagnostics Corp.2002-02-28MOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293509PrimaryGS10
00630414294063Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293509006304142935096304142935090630414293509
00630414294063006304142940636304142940630630414294063

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 15-3 (CA15-3) 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 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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
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