Product code LOJ
- Device name
- Kit, Test,Alpha-Fetoprotein For Testicular Cancer
- 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
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P820060S019 | ABBOTT AXSYM AFP | Abbott Laboratories | 2004-02-02 |
| P820060S016 | ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER | Abbott Laboratories | 2004-02-02 |
| P820060S013 | ABBOTT ARCHITECHT AFP | Abbott Laboratories | 2004-02-02 |
| P820060S017 | AFP CONTROL PACK | Abbott Laboratories | 2003-03-05 |
| P820060S015 | ABBOTT AXSYM AFP | Abbott Laboratories | 2002-09-12 |
| P820060S014 | ABBOTT IMX AFP ASSAY | Abbott Laboratories | 2002-09-05 |
| P820060S012 | ABBOTT AXSYM AFP | Abbott Laboratories | 1997-10-29 |
| P820060S011 | ABBOTT AXSYM AFP | Abbott Laboratories | 1997-05-16 |
| P820060S010 | ABBOTT AXSYM AFP (LIST 7A48) | Abbott Laboratories | 1996-12-02 |
| P820060S009 | ABBOTT AXSYM AFP (LIST 7A48) | Abbott Laboratories | 1995-12-26 |
| P820060S008 | ABBOTT AXSYM AFP (LIST 7A48) | Abbott Laboratories | 1995-03-27 |
| P820060S006 | ABBOTT IMX AFP ADDITIONAL PURIFICATION STEP | Abbott Laboratories | 1993-07-01 |
| P820060S007 | ABBOTT AFP-EIA LABELING CHANGE | Abbott Laboratories | 1993-05-13 |
| P860044S003 | ENZYMUN-TEST{R} AFP | Boehringer Mannheim Corp. | 1991-09-03 |
| P860044S002 | ENZYMUN-TEST{R} AFP | Boehringer Mannheim Corp. | 1991-07-19 |
| P820060S005 | ABBOTT COMMANDER(R) PPC AFP-EIA | Abbott Laboratories | 1990-08-21 |
| P860044S001 | ENZYMUN-TEST{R} AFP | Boehringer Mannheim Corp. | 1990-08-03 |
| P820060S004 | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS | Abbott Laboratories | 1989-05-09 |
| P840035S007 | TANDEM(R)-E AFP | Beckman Coulter, Inc. | 1988-06-03 |
| P840035S003 | TANDEM(R)-E AFP | Beckman Coulter, Inc. | 1988-04-29 |
| P840035S006 | TANDEM(R)-E AFP | Beckman Coulter, Inc. | 1987-08-05 |
| P820060S003 | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER | Abbott Laboratories | 1987-03-09 |
| P840035S004 | TANDEM(R)-E AFP | Beckman Coulter, Inc. | 1986-09-02 |
| P840035S002 | ENCORE AFP | Beckman Coulter, Inc. | 1986-04-08 |
| P840035S001 | TANDEM(R)-E AFP | Beckman Coulter, Inc. | 1986-03-06 |
| P820060S002 | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER | Abbott Laboratories | 1985-05-07 |
| P820060S001 | ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER | Abbott Laboratories | 1983-08-31 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220176 | Elecsys AFP | Roche Diagnostics | 2022-09-15 |
| K213626 | VITROS AFP | Ortho Clinical Diagnostics | 2022-06-15 |
| K090236 | DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 | Siemens Healthcare Diagnostics | 2009-04-27 |
| K081709 | OLYMPUS AFP - ALPHA-FETOPROTEIN | Olympus Life Science Research Europa GmbH (Europa) | 2009-03-16 |
| K080017 | VIDAS AFP ASSAY | bioMerieux, Inc. | 2008-09-26 |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Dade Behring, Inc. | 2008-06-04 |
| K023894 | ST AIA-PACK AFP ENZYME IMMUNOASSAY | Tosoh Medics, Inc. | 2002-12-17 |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-10-01 |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Bayer Corp. | 2002-03-27 |
| K990138 | DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 | Diagnostic Systems Laboratories, Inc. | 1999-06-21 |
| K983031 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-18 |
| K983263 | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 | Diagnostic Products Corp. | 1998-12-07 |
| K981282 | ELECSYS AFP | Roche Diagnostics GmbH | 1998-05-01 |
| K981354 | ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 | Beckman Instruments, Inc. | 1998-05-01 |
| K973351 | ELECSYS AFP | Boehringer Mannheim Corp. | 1997-11-21 |
| K972462 | AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-09-22 |
| K851891 | TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS | Richard Scott Elliott | 1985-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336217146 | Elecsys AFP | Roche Diagnostics GmbH | 2024-10-22 |
| 07613336172025 | Elecsys AFP | Roche Diagnostics GmbH | 2022-12-07 |
| 07613336206164 | Elecsys AFP | Roche Diagnostics GmbH | 2022-12-06 |
| 07613336206157 | Elecsys AFP | Roche Diagnostics GmbH | 2022-12-06 |
| 10758750034819 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2022-10-24 |
| 00630414293561 | Atellica IM Calibrator D | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00816870020440 | AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022123 | AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 960 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022116 | AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022109 | AFP, CEA, PSA Cancer Panel AccuLite VAST CLIA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870021843 | AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020891 | AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020884 | AFP, hCG, uE3 Triple Screen Panel AccuBind VAST ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020464 | AFP AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020457 | AFP AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022147 | Monobind AccuLite AFP CLIA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020433 | AFP, CEA, PSA Cancer Panel AccuBind VAST ELISA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870020426 | Monobind AccuBind AFP, CEA & PSA VAST ELISA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870023281 | AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022550 | AFP, hCG, uE3 Triple Screen Panel AccuLite VAST CLIA Test System - 480 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022543 | Monobind AccuLite AFP, hCG & uE3 VAST CLIA Kit - 192 Wells | MONOBIND, INC. | 2019-02-11 |
| 00816870022130 | AFP AccuLite CLIA Test System - 96 Wells | MONOBIND, INC. | 2019-02-11 |
| 00630414598369 | Atellica IM Calibrator D | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 04015630939909 | Elecsys AFP | Roche Diagnostics GmbH | 2017-04-14 |
| 14560189210230 | ST AIA-PACK AFP | TOSOH CORPORATION | 2016-09-24 |
| 04560189211162 | AIA-PACK AFP Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 04015630938810 | Elecsys AFP Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630920716 | Elecsys AFP Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 10758750000913 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750000876 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |