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

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Primary DI, Brand, Model table
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00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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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