Product Code: MTF


Products Classified as MTF

3125Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer

Total Product Life Cycle (TPLC) Devices

3125Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer

Pre-market Approvals for MTF

P000021DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGESIEMENS HEALTHCARE DIAGNOSTICS
P950021Atellica IM Prostate-Specific Antigen (PSA)SIEMENS HEALTHCARE DIAGNOSTICS
P170037Sangia Total PSA TestOPKO Diagnostics, LLC.
P930027Immulite/Immulite 1000 PSA/Immulite 2000 PSASIEMENS HEALTHCARE DIAGNOSTICS INC.
P850048Access Hybritech PSA Reagents on the Access Immunoassay SystemsBECKMAN COULTER, INC.
P990056Elecsys total PSAROCHE DIAGNOSTICS CORP.
P910065AIA-PACK PSATOSOH BIOSCIENCE, INC.

Global Unique Device Identification Database

00380740008970TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
00630414982281Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414982267Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414982229Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414982212Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414982205Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414954196Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414598451TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
00630414598444TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER
00630414202938Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00630414202921Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00842768016660Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
00842768013874Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
07613336154380Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer
04015630920877TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER

Maude Adverse Events

ALINITY I TOTAL PSA REAGENT KITABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-11
ARCHITECT TOTAL PSAABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-10
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2020-01-31
DIMENSION?SIEMENS HEALTHCARE DIAGNOSTICS INC2020-01-31
DIMENSION?SIEMENS HEALTHCARE DIAGNOSTICS INC2020-01-31
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2019-10-15
ARCHITECT TOTAL PSAABBOTT IRELAND2019-10-15
ARCHITECT TOTAL PSAABBOTT IRELAND2019-09-20
ADVIA CENTAUR XP PSASIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-09-05
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2019-08-20
ADVIA CENTAUR XP PSASIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-08-12
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2019-08-06
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2019-07-30
ARCHITECT TOTAL PSAABBOTT IRELAND2019-07-29
ARCHITECT TOTAL PSAABBOTT IRELAND2019-07-25
ALINITY I TOTAL PSAABBOTT IRELAND2019-07-15
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2019-05-29
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2019-03-20
ARCHITECT TOTAL PSAABBOTT IRELAND2019-03-18
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2019-03-18
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2019-02-19
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2019-01-28
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2019-01-02
ARCHITECT TOTAL PSAABBOTT IRELAND2018-12-21
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2018-12-19
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2018-12-03
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2018-11-19
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2018-10-25
ARCHITECT TOTAL PSAABBOTT IRELAND2018-10-19
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2018-09-21
ARCHITECT TOTAL PSAABBOTT IRELAND2018-08-30
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2018-08-17
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2018-07-17
ADVIA CENTAUR XPT PSA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-07-05
ADVIA CENTAUR XP PSA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-07-05
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2018-06-26
ARCHITECT TOTAL PSAABBOTT IRELAND2018-06-18
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2018-06-11
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2018-05-10
IMMULITE 2000 PSA2018-05-02
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-04-11
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-04-11
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-04-11
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC.2018-04-11
ELECSYS TOTAL PSA IMMUNOASSAYROCHE DIAGNOSTICS2018-04-05
TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)ROCHE DIAGNOSTICS2018-03-12
ADVIA CENTAUR XP CALIBRATOR QSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-01-29
ADVIA CENTAUR XP CALIBRATOR QSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-01-29
ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) ASSAYSIEMENS HEALTHCARE DIAGNOTICS, INC2018-01-29
ADVIA CENTAUR XPT PSA ASSAYSIEMENS HEALTHCARE DIAGNOTICS, INC2018-01-29
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