FDA.reportPublic FDA data

Dimension® clinical chemistry system FPSA Flex® reagent cartridge

Primary DI
00842768013881
Brand
Dimension® clinical chemistry system FPSA Flex® reagent cartridge
Company
Siemens Healthcare Diagnostics Inc.
Model
10444888
Catalog number
RF452
Device description
Heterogeneous Immunoassay Module Free 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
MTGTest,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign ConditionsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P020027001
P020027003
P020027006
P020027008
P020027010
P020027012
P020027014
P020027017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020027001DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027003DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027006DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027008DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027010DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027012DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027014DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG
P020027017DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMSSiemens Healthcare Diagnostics2003-01-24MTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768013881PrimaryGS10
00630414601755Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768013881008427680138818427680138810842768013881
00630414601755006304146017556304146017550630414601755

GMDN Terms#

Term, Definition table
TermDefinition
Free (unbound) prostate specific antigen (fPSA) 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 free (unbound) prostate specific antigen (fPSA) 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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00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590701680Access Hybritech free PSABeckman Coulter, Inc.MTG2025-05-30
00380740130305AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740130312AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740158330AlinityAbbott Ireland DiagnosticsMTG2020-11-18
00380740158347AlinityAbbott Ireland DiagnosticsMTG2020-11-18
07613336166673Elecsys free PSARoche Diagnostics GmbHMTG2020-08-27
07613336166628Elecsys free PSARoche Diagnostics GmbHMTG2020-08-26
07613336168134free PSA CalSetRoche Diagnostics GmbHMTG2020-08-26
04015630940011Elecsys free PSARoche Diagnostics GmbHMTG2018-08-23
07613336154403free PSA CalCheckRoche Diagnostics GmbHMTG2018-06-29
07613336154397Elecsys free PSARoche Diagnostics GmbHMTG2017-09-29
07613336155400free PSA CalsetRoche Diagnostics GmbHMTG2017-09-29
04015630997053Elecsys Free PSA CalCheckRoche Diagnostics GmbHMTG2014-12-18
00380740009007ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00380740009014ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00380740009021ARCHITECTAbbott Ireland DiagnosticsMTG2014-11-18
00842768013751Dimension® clinical chemistry system T/F PSA CalibratorSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768016677Dimension Vista® System FPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00842768024214Dimension Vista® System PSA CALSiemens Healthcare Diagnostics Inc.MTG2014-09-24
00630414971575IMMULITE®/IMMULITE®1000 Systems fPS Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTG2014-09-24
00630414977478IMMULITE® 2000 Systems fPS Free PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTG2014-09-24
H628372101Access Hybritech free PSABeckman Coulter, Inc.MTG2014-09-16
H628372151Access Hyritech free PSA CalibratorsBeckman Coulter, Inc.MTG2014-09-16
04015630919338Elecsys Free PSA CalSetRoche Diagnostics GmbHMTG2014-09-10
04015630919321Elecsys Free PSA ImmunoassayRoche Diagnostics GmbHMTG2014-09-09