System, Test, Carcinoembryonic Antigen

FDA product code DHX · 28 cleared devices

Class 2 Immunology

Regulation: 21 CFR 866.6010
Review panel: IM
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1980-09-26 – 2023-09-22

DHX 2023-09-22

Access CEA

Applicant Beckman Coulter, Inc.

K number K223921

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DHX 2023-08-23

VITROS Immunodiagnostic Products CEA Reagent Pack

Applicant Ortho Clinical Diagnostics

K number K231517

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DHX 2020-04-13

ADVIA Centaur CEA Assay

Applicant Siemens Healthcare Disgnostics, Inc.

K number K200215

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DHX 2009-03-18

OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN

Applicant Olympus America, Inc.

K number K081615

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DHX 2008-10-09

VIDAS CEA (S) ASSAY

Applicant bioMerieux, Inc.

K number K080194

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DHX 2008-06-25

DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)

Applicant Dade Behring, Inc.

K number K071603

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DHX 2004-06-17

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

Applicant Ortho-Clinical Diagnostics, Inc.

K number K041322

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DHX 2003-05-06

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

Applicant Beckman Coulter, Inc.

K number K031270

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DHX 2002-12-18

ST AIA-PACK CEA ENZYME IMMUNOASSAY

Applicant Tosoh Medics, Inc.

K number K023893

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DHX 2001-12-21

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

Applicant Bayer Corp.

K number K013568

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DHX 1999-06-01

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

Applicant Beckman

K number K991707

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DHX 1999-06-01

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK

Applicant Ortho-Clinical Diagnostics, Inc.

K number K990943

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DHX 1999-05-11

ABBOTT ARCHITECT CEA

Applicant Abbott Laboratories

K number K990774

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DHX 1998-09-24

ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

Applicant Beckman Coulter, Inc.

K number K981985

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DHX 1998-08-12

ACS:CENTAUR CEA

Applicant Chiron Diagnostics Corp.

K number K981478

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DHX 1998-06-29

ELECSYS CEA ON THE ELECSYS 1010

Applicant Boehringer Mannheim Corp.

K number K980887

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DHX 1998-04-21

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

Applicant Dpc Cirrus

K number K980855

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DHX 1997-09-22

IMMULITE CEA

Applicant Diagnostic Products Corp.

K number K970877

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DHX 1993-03-18

AIA-PACK CEA CALIBRATION VERIFICATION TEST SET

Applicant Tosoh Medics, Inc.

K number K924857

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DHX 1987-05-21

TRI-LEVEL LIGAND CONTROL

Applicant Ciba Corning Diagnostics Corp.

K number K864877

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DHX 1984-01-03

NORMAL GOAT SERUM

Applicant Biosan Laboratories, Inc.

K number K833318

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DHX 1982-04-08

CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV

Applicant Ventrex Laboratories, Inc.

K number K820298

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DHX 1981-09-29

CEA CONTROL PLASMA

Applicant Pacific Hemostasis

K number K812658

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DHX 1981-08-03

THREE LEVEL CONTROL SERA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K810459

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DHX 1981-06-12

CEA DESALTING DOLUMN SEPHADEX R

Applicant Immuno-Diagnostic Laboratories

K number K811394

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DHX 1981-04-17

AMICON ULTRAFILTRATION MEMBRANES CMII

Applicant Amicon, Inc.

K number K810810

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DHX 1980-09-26

CLINETICS PCA COLUMN

Applicant Clinetics Corp.

K number K801306

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DHX 1980-09-26

CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL

Applicant Environmental Chemical Specialties

K number K792377

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