FDA.reportPublic FDA data

ADVIA Centaur® CA 19-9™ DIL

Primary DI
00630414577128
Brand
ADVIA Centaur® CA 19-9™ DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10491972
Catalog number
10491972
Device description
CA 19-9 Diluent (2PK) - CENTAUR - CAL - 2x5mL
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
NIGSYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031393000BAYER ADVIA CENTAUR CA 19-9 ASSAYBayer Healthcare, LLC2003-06-24NIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414577128PrimaryGS10
00630414005874Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414577128006304145771286304145771280630414577128
00630414005874006304140058746304140058740630414005874

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store upright
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
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15
00630414177021ADVIA Centaur® TSH10309958103099582016-09-24
00630414177038ADVIA Centaur® TSH10309959103099592016-09-24
00630414556093ADVIA Centaur® SHBG Calibrator10285318102853182016-09-24
00630414559704ADVIA Centaur® T3 MCM10361928103619282016-09-24
00630414574516ADVIA® Chemistry Hemoglobin A1c_3 Calibrators10491408104914082016-09-24
00630414579160ADVIA Centaur® iPTH10492369104923692016-09-24
00630414585345ADVIA Centaur® iPTH10493615104936152016-09-24
00630414585352ADVIA Centaur® iPTH10493616104936162016-09-24
00630414587486ADVIA Centaur® iPTH Calibrator10630628106306282016-09-24
00630414587882ADVIA Centaur® Systems VitD Calibrator10630911106309112016-09-24
00630414600611ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents10916067109160672016-09-24
00630414596167Atellica CH ASO_211097634110976342020-09-24
00630414596259Atellica CH PreAlb11097617110976172020-09-24
00630414596440Atellica CH GGT11097597110975972020-09-24
00630414596174Atellica CH hsCRP11097633110976332017-12-21
00630414596198Atellica CH CRP_211097631110976312017-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336218341Elecsys CA 19-9Roche Diagnostics GmbHNIG2026-06-01
10758750034833VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
20758750034830VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
00630414293516Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2020-05-31
14560189213392ST AIA-PACK PROG IITOSOH CORPORATIONNIG2019-07-12
00816870020518CA 19-9 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.NIG2019-02-11
00816870020525CA 19-9 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.NIG2019-02-11
00816870022192CA 19-9 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.NIG2019-02-11
00816870022208CA 19-9 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.NIG2019-02-11
00380740155919AlinityAbbott GmbHNIG2019-01-03
00630414577135ADVIA Centaur® CA 19-9 DILSiemens Healthcare Diagnostics Inc.NIG2018-12-01
00630414598161Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2018-02-06
00380740137304ARCHITECTAbbott GmbHNIG2017-12-29
00630414598192Atellica IM CA 19-9 MCMSiemens Healthcare Diagnostics Inc.NIG2017-12-27
00630414598178Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2017-12-22
00630414598185Atellica IM CA 19-9 DILSiemens Healthcare Diagnostics Inc.NIG2017-12-22
00380740145392ARCHITECTAbbott GmbHNIG2017-05-01
00380740145408ARCHITECTAbbott GmbHNIG2017-05-01
04015630939640Elecsys CA 19-9Roche Diagnostics GmbHNIG2017-04-14
14560189210209ST AIA-PACK CA 19-9TOSOH CORPORATIONNIG2016-09-24
04560189211124AIA-PACK CA 19-9 Sample Diluting SolutionTOSOH CORPORATIONNIG2016-09-24
00842768028533Dimension Vista® Flex® reagent cartridge CA19-9Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414447926ADVIA Centaur® CA 19-9 MCMSiemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414574028ADVIA Centaur® CA 19-9™Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414574257ADVIA Centaur® CA 19-9™Siemens Healthcare Diagnostics Inc.NIG2016-09-24
04015630904297Elecsys CA 199 ImmunoassayRoche Diagnostics GmbHNIG2016-09-20
15099590231842Access GI MonitorBeckman Coulter, Inc.NIG2016-09-09
10758750002351VITROSORTHO CLINICAL DIAGNOSTICSNIG2016-08-26
00380740003555ARCHITECTABBOTT LABORATORIESNIG2016-06-06
00380740003562ARCHITECTABBOTT LABORATORIESNIG2016-06-06