DHX

Product Code: DHX


Products Classified as DHX

3003System, Test, Carcinoembryonic AntigenTumor-associated Antigen Immunological Test System.

Total Product Life Cycle (TPLC) Devices

3003System, Test, Carcinoembryonic AntigenTumor-associated Antigen Immunological Test System.

Pre-market Approvals for DHX

P840019TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAYHYBRITECH, INC.

Pre-market Notifications for DHX

K200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics Inc.
K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENOLYMPUS AMERICA, INC.
K080194VIDAS CEA (S) ASSAYBIOMERIEUX, INC.
K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)DADE BEHRING, INC.
K041322VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.
K031270ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMSBECKMAN COULTER, INC.
K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYTOSOH MEDICS, INC.
K991707MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206BECKMAN
K990943VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACKOrtho-Clinical Diagnostics, Inc.
K990774ABBOTT ARCHITECT CEAABBOTT LABORATORIES
K981985ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209BECKMAN COULTER, INC.
K981478ACS:CENTAUR CEACHIRON DIAGNOSTICS CORP.
K980887ELECSYS CEA ON THE ELECSYS 1010BOEHRINGER MANNHEIM CORP.
K980855IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KITDPC CIRRUS
K970877IMMULITE CEADIAGNOSTIC PRODUCTS CORP.

Global Unique Device Identification Database

00380740130862SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740130855SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740130848SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740130831SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740112424SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740014582SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740014575SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740014551SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00380740014544SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00630414963693SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00630414961125SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00630414961118SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00630414953625SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00630414598536SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
00630414598529SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Maude Adverse Events

ARCHITECT CEAABBOTT IRELAND DIAGNOSTICS DIVISION2020-03-05
ELECSYS CEA ASSAYROCHE DIAGNOSTICS2020-02-17
ARCHITECT CEAABBOTT IRELAND DIAGNOSTICS DIVISION2020-01-29
ATTELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)SIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-10-10
ARCHITECT CEAABBOTT IRELAND2019-07-19
ELECSYS CEA ASSAYROCHE DIAGNOSTICS2019-07-08
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-06-28
ARCHITECT CEAABBOTT IRELAND2019-06-06
ADVIA CENTAUR XPT CEASIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-05-30
ARCHITECT CEAABBOTT IRELAND2019-04-25
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2019-03-14
ARCHITECT CEAABBOTT IRELAND2019-01-30
ARCHITECT CEAABBOTT IRELAND2019-01-08
ARCHITECT CEAABBOTT IRELAND2018-12-04
ARCHITECT CEAABBOTT IRELAND2018-12-03
ELECSYS CEA ASSAYROCHE DIAGNOSTICS2018-11-26
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-11-16
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-11-16
ADVIA CENTAUR XPT CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-11-16
ARCHITECT CEAABBOTT IRELAND2018-10-24
ARCHITECT CEAABBOTT IRELAND2018-09-25
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-09-06
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-09-06
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-09-06
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-09-06
ADVIA CENTAUR XP CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2018-09-06
ELECSYS CEA ASSAYROCHE DIAGNOSTICS2018-08-27
CEA ELECSYSROCHE DIAGNOSTICS2018-07-20
ELECSYS CEA ASSAYROCHE DIAGNOSTICS2018-07-13
CEA ELECSYSROCHE DIAGNOSTICS2018-06-26
ARCHITECT CEAABBOTT IRELAND2018-04-12
ACCESS CEABECKMAN COULTER2018-03-22
ARCHITECT CEAABBOTT IRELAND2018-02-16
IMMULITE 2000/IMMULITE 2000 XPI CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-14
IMMULITE 2000/IMMULITE 2000 XPI CEASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED2017-12-14
ARCHITECT CEAABBOTT IRELAND2017-12-01
ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-10-16
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-08-24
ADVIA CENTAUR XPT CARCINOEMBRYONIC ANTIGEN ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-08-03
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-07-28
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-07-10
ARCHITECT CEAABBOTT IRELAND2017-06-15
COBAS 6000 E 601 MODULEROCHE DIAGNOSTICS2017-06-01
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-04-12
CEA ELECSYSROCHE DIAGNOSTICS2017-03-28
ADVIA CENTAUR XPTSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-03-28
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2017-03-21
ADVIA CENTAUR XPT CEA ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.2017-03-09
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-02-13
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2017-02-06
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.