FDA.reportPublic FDA data

Dimension® clinical chemistry system TPSA Flex® reagent cartridge

Primary DI
00842768013874
Brand
Dimension® clinical chemistry system TPSA Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10444889
Catalog number
RF451
Device description
Heterogeneous Immunoassay Module 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
P000021001
P000021002
P000021003
P000021004
P000021006
P000021010
P000021012
P000021014
P000021015
P000021017
P000021019
P000021023

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000021001DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021002DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021003DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021004DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021006DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021010DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021012DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021014DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021015DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021017DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021019DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ
P000021023DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGESiemens Healthcare Diagnostics2001-07-05LTJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768013874PrimaryGS10
00630414601762Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768013874008427680138748427680138740842768013874
00630414601762006304146017626304146017620630414601762

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) 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
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590701673Access Hybritech PSABeckman Coulter, Inc.MTF2025-05-30
07613336217665Elecsys Total PSARoche Diagnostics GmbHMTF2024-10-24
00380740130411AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740130428AlinityAbbott Ireland DiagnosticsMTF2020-11-18
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
00630414598451Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.MTF2017-12-22
07613336154366Elecsys tPSARoche Diagnostics GmbHMTF2017-09-29
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
00380740008970ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008987ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008994ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00842768016660Dimension Vista® System TPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414202921ADVIA Centaur® Systems, ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414202938ADVIA Centaur® Systems. ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414954196IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982205IMMULITE®/IMMULITE®1000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982212IMMULITE® 2000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982229IMMULITE® 2000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982267IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982281IMMULITE®Systems sPS CONTROL Third Generation PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24