Clinical Chemistry · 9 clearances · 8 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Abbott Laboratories | 2 | 0 | 2023-06-05 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 | 2021-07-13 |
| Diazyme Laboratories, Inc. | 1 | 0 | 2021-12-13 |
| Shenzhen Yhlo Biotech Co., Ltd. | 1 | 0 | 2023-12-11 |
| Shenzhen New Industries Biomedical Engineering Co., Ltd. | 1 | 0 | 2020-01-17 |
| Roche Diagnostics | 1 | 0 | 2021-08-18 |
| Beckman Coulter, Inc. | 1 | 0 | 2022-12-27 |
| Ortho Clinical Diagnostics | 1 | 0 | 2024-05-08 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 84702 | CPT | — | High | hCG (human chorionic gonadotropin) test system; standard pregnancy/tumor marker code |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2024-05-08 | K233581 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack |
| 2023-12-11 | K223690 | Shenzhen Yhlo Biotech Co., Ltd. | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) |
| 2023-06-05 | K230937 | Abbott Laboratories | Alinity i Total ß-hCG Reagent Kit, GLP systems Track |
| 2023-05-19 | K230790 | Abbott Laboratories | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series |
| 2022-12-27 | K221990 | Beckman Coulter, Inc. | Access Total ßhCG (5th IS) |
| 2021-12-13 | K212221 | Diazyme Laboratories, Inc. | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer |
| 2021-08-18 | K203227 | Roche Diagnostics | Elecsys HCG STAT |
| 2021-07-13 | K200210 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur® Total hCG assay |
| 2020-01-17 | K192547 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MAGLUMI 2000 HCG/ß-HCG |