FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge AFP

Primary DI
00842768019937
Brand
Dimension Vista® Flex® reagent cartridge AFP
Company
Siemens Healthcare Diagnostics Inc.
Model
10463378
Catalog number
K6454
Device description
Alpha-Fetoprotein Flex® reagent cartridge, 120 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
LOJKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOJKit, Test,Alpha-Fetoprotein For Testicular CancerImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090236000DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare Diagnostics2009-04-27LOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768019937PrimaryGS10
00630414005515Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768019937008427680199378427680199370842768019937
00630414005515006304140055156304140055150630414005515

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217146Elecsys AFPRoche Diagnostics GmbHLOJ2024-10-22
07613336172025Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-07
07613336206157Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
07613336206164Elecsys AFPRoche Diagnostics GmbHLOJ2022-12-06
10758750034819VITROSORTHO CLINICAL DIAGNOSTICSLOJ2022-10-24
00630414293561Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2020-05-31
00816870020426Monobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020433AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870020440AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870020457AFP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870020464AFP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020884AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870020891AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870021843AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022109AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022116AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
00816870022123AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 WellsMONOBIND, INC.LOJ2019-02-11
00816870022130AFP AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LOJ2019-02-11
00816870022147Monobind AccuLite AFP CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022543Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 WellsMONOBIND, INC.LOJ2019-02-11
00816870022550AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 WellsMONOBIND, INC.LOJ2019-02-11
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00630414598376Atellica IM Calibrator DSiemens Healthcare Diagnostics Inc.LOJ2017-12-27
04015630939909Elecsys AFPRoche Diagnostics GmbHLOJ2017-04-14
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04560189211162AIA-PACK AFP Sample Diluting SolutionTOSOH CORPORATIONLOJ2016-09-24
04015630920716Elecsys AFP AssayRoche Diagnostics GmbHLOJ2016-09-20
04015630938810Elecsys AFP AssayRoche Diagnostics GmbHLOJ2016-09-20
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