| ADVIA Centaur Cytokeratin Fragment 21-1 (K250925) | Fujirebio Diagnostics,Inc. | 2025-12-16 |
| Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) | Fujirebio Diagnostics,Inc. | 2025-05-16 |
| Lumipulse G ß-Amyloid Ratio (1-42/1-40) (DEN200072) | Fujirebio Diagnostics,Inc. | 2022-05-04 |
| Lumipulse G CA15-3 (K192524) | Fujirebio Diagnostics,Inc. | 2020-09-04 |
| ST AIA-PACK BNP (K192380) | Fujirebio Diagnostics,Inc. | 2020-08-24 |
| Lumipulse G CA19-9-N (K200997) | Fujirebio Diagnostics,Inc. | 2020-05-14 |
| Lumipulse G whole PTH (K190702) | Fujirebio Diagnostics,Inc. | 2019-08-30 |
| Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set (K172713) | Fujirebio Diagnostics,Inc. | 2017-12-10 |
| Lumipulse G TSH-III Immunoreaction Cartridges (K171103) | Fujirebio Diagnostics,Inc. | 2017-07-28 |
| Lumipulse G FSH-N Calibrators (K163534) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Progesterone-N Calibrators (K163546) | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| Lumipulse G Prolactin (K163544) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Lumipulse G LH Calibrators (K163521) | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| Lumipulse G E2-III Calibrators (K163053) | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| Lumipulse G TP-N Immunoreaction Cartridge Set (K153145) | Fujirebio Diagnostics,Inc. | 2016-07-05 |
| Lumipulse G ROMA (K160090) | Fujirebio Diagnostics,Inc. | 2016-05-16 |
| ARCHITECT ROMA (K151502) | Fujirebio Diagnostics,Inc. | 2016-04-28 |
| Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators (K153361) | Fujirebio Diagnostics,Inc. | 2016-04-15 |
| Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators (K142895) | Fujirebio Diagnostics,Inc. | 2015-05-21 |
| ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (K140436) | Fujirebio Diagnostics,Inc. | 2014-12-23 |
| FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE (K133197) | Fujirebio Diagnostics,Inc. | 2014-01-17 |
| FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA (K123612) | Fujirebio Diagnostics,Inc. | 2013-01-17 |
| ROMA (HE4 EIA + ARCHITECT CA 125 II) (K103358) | Fujirebio Diagnostics,Inc. | 2011-09-01 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL (K103676) | Fujirebio Diagnostics,Inc. | 2011-07-19 |
| FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL (K110641) | Fujirebio Diagnostics,Inc. | 2011-05-27 |
| CYFRA 21-1 EIA MODEL 211-10 (K100831) | Fujirebio Diagnostics,Inc. | 2011-05-26 |
| FDI GLUCOSE CONTROL SOLUTION FOR AVIVA (K110436) | Fujirebio Diagnostics,Inc. | 2011-04-20 |
| FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE (K103450) | Fujirebio Diagnostics,Inc. | 2011-01-25 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 (K101809) | Fujirebio Diagnostics,Inc. | 2010-10-05 |
| FDI GLUCOSE CONTROL SOLUTIONS (K102260) | Fujirebio Diagnostics,Inc. | 2010-09-24 |
| ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, (K093957) | Fujirebio Diagnostics,Inc. | 2010-03-18 |
| FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 (K092645) | Fujirebio Diagnostics,Inc. | 2009-09-05 |
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| HE4 EIA, MODEL: 404-10 US (K072939) | Fujirebio Diagnostics,Inc. | 2008-06-09 |
| ARCHITECT SIROLIMUS ASSAY (K070822) | Fujirebio Diagnostics,Inc. | 2007-09-28 |
| ARCHITECT TACROLIMUS: MODEL 1L77 (K070820) | Fujirebio Diagnostics,Inc. | 2007-08-01 |
| ARCHITECT BNP ASSAY, MODEL 8K28 (K060964) | Fujirebio Diagnostics,Inc. | 2006-05-25 |
| VITROS CA 19-9 (K052889) | Fujirebio Diagnostics,Inc. | 2005-12-20 |
| ARCHITECT CA 19-9XR ASSAY (K052000) | Fujirebio Diagnostics,Inc. | 2005-10-25 |
| ARCHITECT CA 15-3 ASSAY (K042732) | Fujirebio Diagnostics,Inc. | 2004-12-22 |
| ARCHITECT CA 125 II ASSAY (K042731) | Fujirebio Diagnostics,Inc. | 2004-11-19 |
| AXSYM CORTISOL ASSAY (K033731) | Fujirebio Diagnostics,Inc. | 2004-02-20 |
| FUJIREBIO DIAGNOSTICS CA 19-9 RIA (K020566) | Fujirebio Diagnostics,Inc. | 2002-05-09 |
| OLYMPUS PK(TM) TP (K893124) | Fujirebio Diagnostics,Inc. | 1989-11-17 |