FDA.reportPublic FDA data

IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent

Primary DI
00630414954196
Brand
IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10386994
Catalog number
LPSZ
Device description
PSA Sample Diluent
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
P930027001
P930027004
P930027005

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P930027001IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTSSiemens Healthcare Diagnostics, Inc.1995-09-15MTF
P930027004IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTSSiemens Healthcare Diagnostics, Inc.1995-09-15MTF
P930027005IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTSSiemens Healthcare Diagnostics, Inc.1995-09-15MTF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414954196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414954196006304149541966304149541960630414954196

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, manualA buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from Light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
00842768013874Dimension® clinical chemistry system TPSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MTF2014-09-24
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
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