FDA.reportPublic FDA data

Dimension Vista® System TPSA Flex® Reagent Cartridge

Primary DI
00842768016660
Brand
Dimension Vista® System TPSA Flex® Reagent Cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10445090
Catalog number
K6451
Device description
Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTFTotal,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000021013
P000021018
P000021020
P000021039

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000021013DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021018DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021020DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021039DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768016660PrimaryGS10
00630414601779Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768016660008427680166608427680166600842768016660
00630414601779006304146017796304146017790630414601779

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) 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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740158316AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740158323AlinityAbbott Ireland DiagnosticsMTF2020-11-18
07613336165980Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336165997Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336166000Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336167496total PSA CalSet IIRoche Diagnostics GmbHMTF2020-08-24
04015630939824Elecsys total PSARoche Diagnostics GmbHMTF2018-07-16
00630414598444Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.MTF2017-12-27
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07613336154373Elecsys tPSARoche Diagnostics GmbHMTF2017-09-29
07613336154380total PSA Calset IIRoche Diagnostics GmbHMTF2017-09-29
04015630920754Elecsys Total PSA CalSet IIRoche Diagnostics GmbHMTF2014-12-18
00380740008963ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
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