Product code DHX
- Device name
- System, Test, Carcinoembryonic Antigen
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.6010
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P840019S012 | TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1996-03-07 |
| P920021S001 | OPUS(R) CEA TEST SYSTEM | Behring Diagnostics, Inc. | 1996-02-23 |
| P830066S012 | ABBOTT CEA-RIA MONOCLONAL | Abbott Laboratories | 1995-07-12 |
| P830066S011 | ABBOTT AXSYM CEA (LIST 7A47) | Abbott Laboratories | 1995-03-27 |
| P840019S010 | STRATUS (R) CEA FLUOROMETRIC ENZYME IMMUNOASSAY | Hybritech, Inc. | 1994-03-17 |
| P840019S011 | TANDEM(R) R CEA IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1994-01-13 |
| P860058S001 | ENZYMUN TEST{R} CEA | Boehringer Mannheim Corp. | 1993-07-29 |
| P830066S009 | ABBOTT IMX-CEA (LIST 3A33) | Abbott Laboratories | 1992-07-17 |
| P840019S009 | TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY | Hybritech, Inc. | 1990-04-17 |
| P830066S008 | ABBOTT CEA-EIA | Abbott Laboratories | 1990-01-10 |
| P840019S008 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1989-12-13 |
| P830066S007 | ABBOTT CEA-EIA | Abbott Laboratories | 1989-12-13 |
| P840019S007 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1989-09-06 |
| P840027S006 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1989-05-01 |
| P840027S005 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1989-05-01 |
| P840027S004 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1988-11-29 |
| P840027S003 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1988-07-07 |
| P830066S006 | ABBOTT CEA-EIA | Abbott Laboratories | 1988-03-28 |
| P830066S004 | ABBOTT CEA-EIA ONE-STEP | Abbott Laboratories | 1987-11-02 |
| P840019S006 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1987-04-30 |
| P840027S002 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1987-02-19 |
| P840019S005 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1986-11-05 |
| P840019S004 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1986-09-23 |
| P840027S001 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1986-09-08 |
| P830066S003 | ABBOTT CEA-EIA KIT | Abbott Laboratories | 1986-07-07 |
| P830066S002 | ABBOTT CEA-EIA KIT | Abbott Laboratories | 1986-07-07 |
| P840019S003 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1986-03-06 |
| P840027 | CEA-ROCHE(R) EIA | Roche Diagnostics GmbH | 1985-05-13 |
| P840019S002 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1985-05-03 |
| P840019S001 | TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY | Hybritech, Inc. | 1985-03-25 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223921 | Access CEA | Beckman Coulter, Inc. | 2023-09-22 |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho Clinical Diagnostics | 2023-08-23 |
| K200215 | ADVIA Centaur CEA Assay | Siemens Healthcare Disgnostics, Inc. | 2020-04-13 |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Olympus America, Inc. | 2009-03-18 |
| K080194 | VIDAS CEA (S) ASSAY | bioMerieux, Inc. | 2008-10-09 |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Dade Behring, Inc. | 2008-06-25 |
| K041322 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 2004-06-17 |
| K031270 | ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2003-05-06 |
| K023893 | ST AIA-PACK CEA ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-18 |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Corp. | 2001-12-21 |
| K991707 | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 | Beckman | 1999-06-01 |
| K990943 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 1999-06-01 |
| K990774 | ABBOTT ARCHITECT CEA | Abbott Laboratories | 1999-05-11 |
| K981985 | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 | Beckman Coulter, Inc. | 1998-09-24 |
| K981478 | ACS:CENTAUR CEA | Chiron Diagnostics Corp. | 1998-08-12 |
| K980887 | ELECSYS CEA ON THE ELECSYS 1010 | Boehringer Mannheim Corp. | 1998-06-29 |
| K980855 | IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT | Dpc Cirrus | 1998-04-21 |
| K970877 | IMMULITE CEA | Diagnostic Products Corp. | 1997-09-22 |
| K924857 | AIA-PACK CEA CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1993-03-18 |
| K864877 | TRI-LEVEL LIGAND CONTROL | Ciba Corning Diagnostics Corp. | 1987-05-21 |
| K833318 | NORMAL GOAT SERUM | Biosan Laboratories, Inc. | 1984-01-03 |
| K820298 | CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV | Ventrex Laboratories, Inc. | 1982-04-08 |
| K812658 | CEA CONTROL PLASMA | Pacific Hemostasis | 1981-09-29 |
| K810459 | THREE LEVEL CONTROL SERA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-08-03 |
| K811394 | CEA DESALTING DOLUMN SEPHADEX R | Immuno-Diagnostic Laboratories | 1981-06-12 |
| K810810 | AMICON ULTRAFILTRATION MEMBRANES CMII | Amicon, Inc. | 1981-04-17 |
| K801306 | CLINETICS PCA COLUMN | Clinetics Corp. | 1980-09-26 |
| K792377 | CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL | Environmental Chemical Specialties | 1980-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278620873 | MAC | Ge Medical Systems Information Technologies, Inc. | 2026-03-31 |
| 07613336218358 | Elecsys CEA | Roche Diagnostics GmbH | 2025-11-07 |
| 10758750034307 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-01-20 |
| 20758750034304 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-01-20 |
| 00630414293585 | Atellica IM CEA | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294131 | Atellica IM CEA | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 04560189212244 | AIA-PACK CEA Calibration Verification Test Set | TOSOH CORPORATION | 2019-07-25 |
| 14560189212241 | AIA-PACK CEA Calibration Verification Test Set | TOSOH CORPORATION | 2019-07-25 |
| 00816870020549 | CEA AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022246 | Monobind AccuLite CEA Next Generation CLIA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022239 | CEA-NG AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022222 | CEA AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022215 | CEA AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020563 | CEA-NG AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020556 | CEA-NG AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020532 | CEA AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 04015630940370 | Elecsys Anti-CCP | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630939664 | Elecsys CEA | Roche Diagnostics GmbH | 2017-04-14 |
| 14560189210780 | ST AIA-PACK CEA | TOSOH CORPORATION | 2016-09-24 |
| 04560189211780 | AIA-PACK CEA Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 00842768019920 | Dimension Vista® Flex® reagent cartridge CEA | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414126302 | ADVIA Centaur® CEA MCM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630938919 | Elecsys CEA Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630938766 | Elecsys CEA Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 15099590624811 | Access CEA QC | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590624828 | Access CEA Diluent | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590624835 | Access CEA Calibrators | Beckman Coulter, Inc. | 2016-09-09 |
| 15099590624842 | Access CEA | Beckman Coulter, Inc. | 2016-09-09 |
| 03573026229795 | VIDAS® CEA (S) | BIOMERIEUX SA | 2016-08-31 |
| 10758750000258 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |