| K233581 | ortho clinical diagnostics | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | May 8, 2024 |
| K223690 | shenzhen yhlo biotech co | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | December 11, 2023 |
| K230937 | abbott laboratories | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | June 5, 2023 |
| K230790 | abbott laboratories | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT | May 19, 2023 |
| K221990 | beckman coulter | Access Total ßhCG (5th IS) | December 27, 2022 |
| K212221 | diazyme laboratories | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu | December 13, 2021 |
| K203227 | roche diagnostics | Elecsys HCG STAT | August 18, 2021 |
| K200210 | siemens healthcare diagnostics | ADVIA Centaur® Total hCG assay | July 13, 2021 |
| K192547 | shenzhen new industries biomedical engineering co | MAGLUMI 2000 HCG/ß-HCG | January 17, 2020 |
| K192790 | siemens healthcare diagnostics | Atellica IM Total hCG (ThCG) | October 30, 2019 |
| K170317 | abbott laboratories | Alinity i Total ß-hCG Reagent Kit, Alinity i System | October 23, 2017 |
| K163418 | diazyme laboratories | Diazyme DZ-Lite Total beta-hCG Test System | August 18, 2017 |
| K133002 | abbott point of care | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hC | April 16, 2015 |
| K130020 | beckman coulter | ACCESS TOTAL BHCG (5TH IS) | October 1, 2013 |
| K131037 | diasorin | LIAISON XL HCG | September 6, 2013 |
| K072500 | guangzhou wondfo biotech co | ONE STEP HCG URINE/SERUM TEST | April 21, 2009 |
| K080094 | olympus life science research europa gmbh (europa) | OLYMPUS TOTAL BHCG TEST SYSTEN | September 3, 2008 |
| K063720 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE | April 9, 2007 |
| K063754 | dade behring | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# | February 23, 2007 |
| K060548 | dade behring | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AN | April 6, 2006 |