LTK

Product Code: LTK


Products Classified as LTK

3040Test, Epithelial Ovarian Tumor-associated Antigen (ca125)Tumor-associated Antigen Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3040Test, Epithelial Ovarian Tumor-associated Antigen (ca125)Tumor-associated Antigen Immunological Test System.

Pre-market Notifications for LTK

K200199ADVIA Centaur CA 125IISiemens Healthcare Diagnostics, Inc.
K143534Elecsys CA-125 II AssayROCHE PROFESSIONAL DIAGNOSTICS
K142895LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II CalibratorsFUJIREBIO DIAGNOSTICS, INC
K100321DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604SIEMENS HEALTHCARE DIAGNOSTICS
K080561VIDAS CA 125 II ASSAYBIOMERIEUX, INC.
K080469VIDAS CA 15-3 ASSAYBIOMERIEUX, INC.
K042731ARCHITECT CA 125 II ASSAYFUJIREBIO DIAGNOSTICS, INC.
K031297ACCESS OV MONITOR ASSAYBECKMAN COULTER, INC.
K023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYTOSOH MEDICS, INC.
K022329CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBAYER DIAGNOSTICS CORP.
K020828CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEMBAYER CORP.
K990431AIA-PACK CA 125TOSOH MEDICS, INC.
K983875VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACKOrtho-Clinical Diagnostics, Inc.
K983715THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)BAYER CORP.
K983391IMMULITE 2000 OM-MA MODEL L2KOP2DIAGNOSTIC PRODUCTS CORP.

Global Unique Device Identification Database

00380740145385TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00380740145378TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00380740145361TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00380740131050TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00380740003388TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00380740003371TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00380740003364TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414964331TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414961798TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414954219TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414954134TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414954127TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414598116TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414598109TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
00630414598093TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

Maude Adverse Events

ADVIA CENTAUR XP CA125 IISIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-20
ADVIA CENTAUR XP CA125 IISIEMENS HEALTHCARE DIAGNOSTICS, INC.2020-02-20
ARCHITECT CA 125 IIABBOTT GMBH2020-01-02
ARCHITECT CA 125 IIABBOTT GERMANY2019-11-19
ALINITY CA 125 II REAGENTABBOTT GERMANY2019-09-10
ARCHITECT CA 125 IIABBOTT GERMANY2019-08-05
ARCHITECT CA 125 IIABBOTT LABORATORIES2019-07-10
ARCHITECT CA 125 IIABBOTT GERMANY2019-06-17
ARCHITECT CA 125 IIABBOTT LABORATORIES2019-06-12
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-05-13
ADVIA CENTAUR XP CA 125IISIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-04-25
ARCHITECT CA 125 IIABBOTT LABORATORIES2019-04-03
ARCHITECT CA 125 IIABBOTT LABORATORIES2019-02-28
ARCHITECT CA 125 IIABBOTT LABORATORIES2019-02-13
ARCHITECT CA 125 IIABBOTT GERMANY2019-02-01
ARCHITECT CA 125 IIABBOTT LABORATORIES2019-01-31
ELECSYS CA 125 IIROCHE DIAGNOSTICS2019-01-28
ELECSYS CA 125 IIROCHE DIAGNOSTICS2019-01-28
ARCHITECT CA 125 IIABBOTT LABORATORIES2018-10-25
VIDAS? CA 15-3 ASSAYBIOMERIEUX, S.A.2018-07-05
ELECSYS CA 125 IIROCHE DIAGNOSTICS2018-05-16
VIDAS? CA 15-3 ASSAYBIOMERIEUX SA2018-04-26
VIDAS? CA 15-3 ASSAYBIOMERIEUX, SA2018-03-08
ARCHITECT CA 125 IIABBOTT LABORATORIES2018-01-18
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-01-09
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-01-05
COBAS 8000 E 801 MODULEROCHE DIAGNOSTICS2017-12-22
ARCHITECT I2000SR ANALYZERABBOTT MANUFACTURING INC2017-12-21
IMMULITE 2000/IMMULITE 2000 XPI OM-MASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-14
IMMULITE/IMMULITE 1000 OM-MASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-14
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-12-01
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-12-01
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-11-21
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-11-21
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-09-19
ADVIA CENTAUR XP CA 125II IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-09-13
ADVIA CENTAUR XP CA 125II IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-09-13
ARCHITECT CA 125 IIABBOTT GERMANY2017-08-29
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-08-25
ARCHITECT I2000SR ANALYZERABBOTT MANUFACTURING INC2017-08-15
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-07-27
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-07-25
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-07-12
ARCHITECT I2000SR ANALYZERABBOTT MANUFACTURING INC2017-06-12
ARCHITECT CA 125 IIABBOTT LABORATORIES2017-01-26
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-01-06
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2016-12-07
ARCHITECT CA 125 IIABBOTT LABORATORIES2016-11-13
ADVIA CENTAUR XP CA 125II ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2016-11-03
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2016-10-27

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