FDA.reportPublic FDA data

Atellica IM CEA

Primary DI
00630414294131
Brand
Atellica IM CEA
Company
Siemens Healthcare Diagnostics Inc.
Model
11206246
Catalog number
11206246
Device description
CEA - 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
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
00630414293585PrimaryGS10
00630414294131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293585006304142935856304142935850630414293585
00630414294131006304142941316304142941310630414294131

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
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
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
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
00630414126302ADVIA Centaur® CEA MCMSiemens Healthcare Diagnostics Inc.DHX2016-09-24