FDA.reportPublic FDA data

Elecsys Total PSA CalSet II

Primary DI
04015630920754
Brand
Elecsys Total PSA CalSet II
Company
Roche Diagnostics GmbH
Model
04485220160
Catalog number
04485220160
Published
2014-12-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
P990056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990056000ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSETRoche Diagnostics Corp.2000-11-22MTF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630920754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630920754040156309207544015630920754

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

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
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
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