| Z-1227-2023 | Class II | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human ci | February 1, 2023 |
| Z-1743-2022 | Class III | BIOPHEN UFH Control Plasma | June 28, 2022 |
| Z-2346-2019 | Class II | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | July 19, 2019 |
| Z-2347-2019 | Class II | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. | July 19, 2019 |
| Z-1188-2019 | Class III | BIOPHEN UFH Control C2, REF 223901 | March 19, 2019 |
| Z-1190-2019 | Class III | BIOPHEN LMWH Control C4, REF 224201 | March 19, 2019 |
| Z-1189-2019 | Class III | BIOPHEN UFH Control C1, REF 224101 | March 19, 2019 |