Home GUDID 07613336217672 Elecsys free PSA
Primary DI 07613336217672
Brand Elecsys free PSA
Company Roche Diagnostics GmbH
Model 09744908190
Catalog number 09744908190
Published 2024-10-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LTJ PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07613336217672 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07613336217672 07613336217672 7613336217672
GMDN Terms# Term, Definition table Term Definition Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay 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 any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen, using a chemiluminescent immunoassay 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 DI Brand Model Catalog Published 07613336171509 Elecsys Calcitonin 09005676190 09005676190 2026-06-01 07613336171516 CalSet Calcitonin 09005684190 09005684190 2026-06-01 07613336188064 Elecsys Calcitonin 09005668160 09005668160 2026-06-01 07613336217641 Elecsys Anti-TSHR 09744819190 09744819190 2026-06-01 07613336218341 Elecsys CA 19-9 09755608190 09755608190 2026-06-01 07613336218389 Elecsys Estradiol III 09755659190 09755659190 2026-06-01 07613336235546 PreciControl HIV Gen II 09465006160 09465006160 2026-05-22 07613336234457 PreciControl Syphilis 09465022190 09465022190 2026-05-15 07613336231432 Tina-quant Antistreptolysin-O II 09537368190 09537368190 2026-05-08 07613336231449 Tina-quant Antistreptolysin-O II 09537341190 09537341190 2026-05-08 07613336154342 Elecsys Anti-HBc IgM 11820567160 11820567160 2017-09-29 07613336217832 Elecsys Testosterone II 09745963190 09745963190 2026-04-21 07613336153932 Elecsys Anti-HBc IgM 07026811160 07026811160 2018-03-19 00875197004748 cobas® HBV/HCV/HIV-1 Control Kit 1.0 06998887190 2015-12-04 07613336203606 Elecsys Anti-HBc II 09014918160 09014918160 2022-04-11 07613336203613 Elecsys Anti-HBc II 09014926160 09014926160 2022-04-11 04015630938858 Elecsys AntiHAV IgM 11820591160 11820591160 2016-09-20 04015630939855 Elecsys Anti-HAV IgM 07026773190 07026773190 2017-09-07 07613336224397 cobas ISE neo 1800 analytical unit 09687416001 09687416001 2026-04-03 20875197004766 cobas® MPX (96 tests) 06998909190 06998909190 2017-02-14
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00630414293738 Atellica IM PSA Siemens Healthcare Diagnostics Inc. LTJ 2020-05-31 00630414294230 Atellica IM PSA Siemens Healthcare Diagnostics Inc. LTJ 2020-05-31 00816870020594 Free fPSA AccuBind ELISA Test System - 96 Wells MONOBIND, INC. LTJ 2019-02-11 00816870020600 Free fPSA AccuBind ELISA Test System - 192 Wells MONOBIND, INC. LTJ 2019-02-11 00816870020617 Total PSA AccuBind ELISA Test System - 96 Wells MONOBIND, INC. LTJ 2019-02-11 00816870020624 Total PSA AccuBind ELISA Test System - 192 Wells MONOBIND, INC. LTJ 2019-02-11 00816870020631 Total PSA Extra Sensitive AccuBind ELISA Test System - 96 Wells MONOBIND, INC. LTJ 2019-02-11 00816870020648 Total PSA Extra Sensitive AccuBind ELISA Test System - 192 Wells MONOBIND, INC. LTJ 2019-02-11 00816870022277 Free PSA AccuLite CLIA Test System - 96 Wells MONOBIND, INC. LTJ 2019-02-11 00816870022284 Monobind AccuLite Free PSA CLIA Kit - 192 Wells MONOBIND, INC. LTJ 2019-02-11 00816870022291 Total PSA AccuLite CLIA Test System - 96 Wells MONOBIND, INC. LTJ 2019-02-11 00816870022307 Total PSA AccuLite CLIA Test System - 192 Wells MONOBIND, INC. LTJ 2019-02-11 00816870022314 Total PSA Extra Sensitive AccuLite CLIA Test System - 96 Wells MONOBIND, INC. LTJ 2019-02-11 00816870022321 Total PSA Extra Sensitive AccuLite CLIA Test System - 192 Wells MONOBIND, INC. LTJ 2019-02-11 00630414599809 Atellica IM PSA Siemens Healthcare Diagnostics Inc. LTJ 2018-11-14 00630414599816 Atellica IM PSA Siemens Healthcare Diagnostics Inc. LTJ 2018-11-14 00630414599823 Atellica IM PSA MCM Siemens Healthcare Diagnostics Inc. LTJ 2018-11-14 08809317540481 FREND PSA Plus NanoEnTek, Inc. LTJ 2018-05-04 30816467020014 FastPack® IP Total PSA Kit (90) QUALIGEN INC. LTJ 2017-09-14 08809317540184 FREND PSA Plus NanoEnTek, Inc. LTJ 2016-09-30 10816467020010 FastPack® Total PSA Kit (50) QUALIGEN INC. LTJ 2016-09-16 20816467020017 FastPack® IP Total PSA Kit (30) QUALIGEN INC. LTJ 2016-09-16 10758750000319 VITROS ORTHO CLINICAL DIAGNOSTICS LTJ 2016-08-26 10758750001309 VITROS ORTHO CLINICAL DIAGNOSTICS LTJ 2016-08-26 00380740008963 ARCHITECT Abbott Ireland Diagnostics LTJ 2014-11-18 00380740008970 ARCHITECT Abbott Ireland Diagnostics LTJ 2014-11-18 00380740008987 ARCHITECT Abbott Ireland Diagnostics LTJ 2014-11-18 00380740008994 ARCHITECT Abbott Ireland Diagnostics LTJ 2014-11-18 14560189212104 ST AIA-PACK PA TOSOH CORPORATION LTJ 2014-09-24 00630414202952 ADVIA Centaur® Systems, ACS 180® Systems PSA MCM Siemens Healthcare Diagnostics Inc. LTJ 2014-09-24