FDA.reportPublic FDA data

Atellica IM CA 19-9

Primary DI
00630414598178
Brand
Atellica IM CA 19-9
Company
Siemens Healthcare Diagnostics Inc.
Model
10995490
Catalog number
10995490
Device description
CA 19-9 - Atellica IM - RGT 50T
Published
2017-12-22
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
00630414598178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598178006304145981786304145981780630414598178

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 19-9 (CA19-9) 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 19-9 (CA19-9) in a clinical specimen, using a chemiluminescent immunoassay method. CA19-9 is typically used as a marker commonly associated with gastrointestinal, pancreatic, bile duct and gallbladder cancer.

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
1
Lot or batch
true
Expiration date on label
true

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
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
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
00630414577128ADVIA Centaur® CA 19-9™ DILSiemens 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
00380740105464ARCHITECTABBOTT LABORATORIESNIG2016-06-06