FDA.reportPublic FDA data

ADVIA Centaur® CEA

Primary DI
00630414204741
Brand
ADVIA Centaur® CEA
Company
Siemens Healthcare Diagnostics Inc.
Model
10333162
Catalog number
118808
Device description
Carcino-Embryonic Antigen (Ref) - CENTAUR - RGT - 500 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DHXSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981478000ACS:CENTAUR CEAChiron Diagnostics Corp.1998-08-12DHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414204741PrimaryGS10
00630414010632Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414204741006304142047416304142047410630414204741
00630414010632006304140106326304140106320630414010632

GMDN Terms#

Term, Definition table
TermDefinition
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carcinoembryonic antigen (CEA) 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, Do not freeze, Resuspend.
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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278840202MACGe Medical Systems Information Technologies, Inc.DHX2026-10-13
00195278620873MACGe Medical Systems Information Technologies, Inc.DHX2026-03-31
07613336218358Elecsys CEARoche Diagnostics GmbHDHX2025-11-07
10758750034307VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
20758750034304VITROSORTHO CLINICAL DIAGNOSTICSDHX2024-01-20
00630414293585Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
00630414294131Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2020-05-31
04560189212244AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
14560189212241AIA-PACK CEA Calibration Verification Test SetTOSOH CORPORATIONDHX2019-07-25
00816870020532CEA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020549CEA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870020556CEA-NG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870020563CEA-NG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022215CEA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022222CEA AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DHX2019-02-11
00816870022239CEA-NG AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DHX2019-02-11
00816870022246Monobind AccuLite CEA Next Generation CLIA Kit - 192 WellsMONOBIND, INC.DHX2019-02-11
00380740130831AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130848AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130855AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00380740130862AlinityAbbott Ireland DiagnosticsDHX2018-12-31
00630414598505Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598536Atellica IM CEA MCMSiemens Healthcare Diagnostics Inc.DHX2018-02-06
00630414598529Atellica IM CEA DILSiemens Healthcare Diagnostics Inc.DHX2017-12-27
00630414598512Atellica IM CEASiemens Healthcare Diagnostics Inc.DHX2017-12-22
04015630940370Elecsys Anti-CCPRoche Diagnostics GmbHDHX2017-04-21
04015630939664Elecsys CEARoche Diagnostics GmbHDHX2017-04-14
14560189210780ST AIA-PACK CEATOSOH CORPORATIONDHX2016-09-24
04560189211780AIA-PACK CEA Sample Diluting SolutionTOSOH CORPORATIONDHX2016-09-24
00842768019920Dimension Vista® Flex® reagent cartridge CEASiemens Healthcare Diagnostics Inc.DHX2016-09-24