| Access OV Monitor (K240479) | Beckman Coulter, Inc. | 2024-05-10 |
| IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (K213510) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-09-08 |
| VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355) | Ortho Clinical Diagnostics | 2022-12-12 |
| ADVIA Centaur CA 125II (K200199) | Siemens Healthcare Diagnostics, Inc. | 2020-04-06 |
| Elecsys CA-125 II assay (K143534) | Roche Professional Diagnostics | 2015-08-06 |
| LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators (K142895) | Fujirebio Diagnostics,Inc. | 2015-05-21 |
| DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 (K100321) | Siemens Healthcare Diagnostics | 2011-04-12 |
| VIDAS CA 15-3 ASSAY (K080469) | bioMerieux, Inc. | 2009-06-22 |
| VIDAS CA 125 II ASSAY (K080561) | bioMerieux, Inc. | 2009-04-10 |
| IMMULITE 2500 OM-MA, MODEL L5KOP (K072794) | Siemens Medical Solutions Diagnostics | 2007-11-05 |
| ARCHITECT CA 125 II ASSAY (K042731) | Fujirebio Diagnostics,Inc. | 2004-11-19 |
| ACCESS OV MONITOR ASSAY (K031297) | Beckman Coulter, Inc. | 2003-05-02 |
| ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY (K023597) | Beckman Coulter, Inc. | 2002-12-11 |
| ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (K023891) | Tosoh Medics, Inc. | 2002-12-06 |
| CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022329) | Bayer Diagnostics Corp. | 2002-11-27 |
| CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K020828) | Bayer Corp. | 2002-07-24 |
| AIA-PACK CA 125 (K990431) | Tosoh Medics, Inc. | 1999-06-03 |
| THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K983715) | Bayer Corp. | 1999-05-14 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK (K983875) | Ortho-Clinical Diagnostics, Inc. | 1999-05-14 |
| IMMULITE 2000 OM-MA MODEL L2KOP2 (K983391) | Diagnostic Products Corp. | 1998-10-15 |
| IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 (K981297) | Diagnostic Products Corp. | 1998-09-18 |
| ELECSYS CA 125II ON THE ELECSYS 1010 (K980240) | Boehringer Mannheim Corp. | 1998-03-25 |
| ELECSYS CA 125 II (K972162) | Boehringer Mannheim Corp. | 1998-03-18 |
| IMX CA 125 (K964185) | Abbott Diagnostics | 1997-11-04 |
| AXSYM CA 125 (K964020) | Abbott Laboratories | 1997-11-04 |
| CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964098) | Bayer Corp. | 1997-10-31 |