| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024-05-08 |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023-06-05 |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | Abbott Laboratories | 2023-05-19 |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022-12-27 |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | Diazyme Laboratories, Inc. | 2021-12-13 |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | 2021-08-18 |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 |
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| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017-10-23 |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories | 2017-08-18 |
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| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 |
| K080094 | OLYMPUS TOTAL BHCG TEST SYSTEN | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 |
| K063720 | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS | Ortho-Clinical Diagnostics | 2007-04-09 |
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| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY | Nichols Institute Diagnostics | 2004-12-17 |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Diagnostic Products Corp. | 2003-12-12 |
| K031052 | CARESTART HCG ONE-STEP PREGNANCY TEST | Access Bio Incorporate | 2003-06-13 |
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| K022680 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) | Azog, Inc. | 2002-11-01 |
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| K013678 | VICTORCH MEDITEK'S HCG TEST CARD | Victorch Meditek, Inc. | 2001-12-27 |
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| K003178 | ELECSYS HCG AND BETA TEST SYSTEM | Roche Diagnostics Corp. | 2000-12-14 |
| K002148 | ELECSYS HCG TEST SYSTEM | Roche Diagnostics Corp. | 2000-08-22 |