LTJ

Product Code: LTJ


Products Classified as LTJ

3039Prostate-specific Antigen (psa) For Management Of Prostate CancersTumor-associated Antigen Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3039Prostate-specific Antigen (psa) For Management Of Prostate CancersTumor-associated Antigen Immunological Test System.

Pre-market Approvals for LTJ

P930027IMMULITE PSA CATALOG # LKPS1,5)SIEMENS HEALTHCARE DIAGNOSTICS INC.
P850048ACCESS(R) HYBRITECH PSA ASSAYBECKMAN COULTER, INC.
P910065AIA PACK PATOSOH BIOSCIENCE, INC.
P950021ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS
P990056ELECSYS TOTAL PSA IMMUNOASSAY/TOTAL PSA CALSETROCHE DIAGNOSTICS CORP.
P000027Elecsys free PSAROCHE DIAGNOSTICS CORP.
P000021Dimension TPSA Flex Reagent CartridgeSIEMENS HEALTHCARE DIAGNOSTICS

Pre-market Notifications for LTJ

K162378FREND PSA PLUS (reagent Cartridge)NANOENTEK USA INC
K124056FREND PSA PLUS (REAGENT CARTRIDGE)NANOEN TEK, INC.
K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBAYER CORP.
K010550VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428BIOMERIEUX, INC.
K003963DIMENSION PSA FLEX REAGENT CARTRIDGEDADE BEHRING, INC.
K003094FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZERQualigen, Inc.
K002376ADVIA: CENTAUR AND ACS: 180 CPSA ASSAYBAYER CORP.
K002313COMPLEXED PSA MICROTITER ELISAONCOGENE SCIENCE, INC.
K002121TOTAL PSA MICROTITER ELISAONCOGENE SCIENCE, INC.
K000566MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORSOrtho-Clinical Diagnostics, Inc.
K994419FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEMQUALISYS DIAGNOSTICS, INC.
K994221BAYER PSA ASSAYBAYER CORP.
K990234QUALISYS PSA IMMUNOASSAYQUALISYS DIAGNOSTICS, INC.
K984289VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACKOrtho-Clinical Diagnostics, Inc.
K982948ELECSYS PSA, MODEL # ELECSYS 1010BOEHRINGER MANNHEIM CORP.

Global Unique Device Identification Database

00380740008987PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
00380740008963PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
00630414599823PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
00630414599816PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
00630414599809PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
00630414203003Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
00630414202990Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
00630414202952Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
30816467020014Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
20816467020017Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
14560189212104Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
10816467020010Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
10758750001309PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
10758750000319PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
08809317540481Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Maude Adverse Events

ARCHITECT TOTAL PSAABBOTT IRELAND DIAGNOSTICS DIVISION2020-02-21
ARCHITECT TOTAL PSAABBOTT IRELAND DIAGNOSTICS DIVISION2020-01-20
ARCHITECT TOTAL PSAABBOTT IRELAND2019-08-16
ARCHITECT TOTAL PSAABBOTT IRELAND2019-07-23
ARCHITECT TOTAL PSAABBOTT IRELAND2019-07-18
ARCHITECT TOTAL PSAABBOTT IRELAND2019-06-28
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-04-22
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2019-04-22
ARCHITECT TOTAL PSAABBOTT IRELAND2019-03-20
VIDAS? TPSABIOMERIEUX SA2019-01-24
VIDAS? TPSABIOMERIEUX SA2019-01-24
VIDAS? TPSABIOMERIEUX SA2019-01-24
FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUESQUALIGEN, INC.2018-12-13
FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUESQUALIGEN, INC.2018-12-13
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-11-29
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACKORTHO-CLINICAL DIAGNOSTICS2018-11-29
ARCHITECT TOTAL PSAABBOTT IRELAND2018-11-13
ARCHITECT TOTAL PSAABBOTT IRELAND2018-11-13
ARCHITECT TOTAL PSAABBOTT IRELAND2018-10-10
ELECSYS 2010 ANALYZERROCHE DIAGNOSTICS2018-04-16
ARCHITECT TOTAL PSAABBOTT IRELAND2018-04-06
ADVIA CENTAUR CPSIEMENS HEALTHCARE DIAGNOSTICS INC.2018-03-28
ARCHITECT TOTAL PSAABBOTT IRELAND2018-02-21
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2018-02-15
ADVIA CENTAUR CPSIEMENS HEALTHCARE DIAGNOSTICS INC.2018-01-29
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-11-16
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-11-16
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-11-16
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-11-14
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-11-14
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-11-08
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-11-07
ADVIA CENTAUR XPTSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-26
ACCESS HYBRITECH PSA REAGENTBECKMAN COULTER2017-10-23
DIMENSION VISTA?SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW2017-10-19
ARCHITECT TOTAL PSAABBOTT IRELAND2017-10-17
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-10-12
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-10-10
DIMENSION VISTA 500SIEMENS HEALTHCARE DIAGNOSTICS INC.2017-10-09
PSA HOME MICRO PROSTATE CANCER TESTPINNACLE LABS2017-09-25
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-09-21
ARCHITECT I2000SR ANALYZERABBOTT MANUFACTURING INC2017-09-20
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-09-15
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-09-11
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-08-24
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-08-18
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-08-18
ARCHITECT TOTAL PSAABBOTT IRELAND2017-08-18
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-08-17
COBAS 8000 E 602 MODULEROCHE DIAGNOSTICS2017-08-14
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