| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Quidel Corporation | 2 | 0 | 2023-12-13 |
| Healgen Scientific,, LLC | 1 | 0 | 2024-04-19 |
| Nano-Ditech Corporation | 1 | 0 | 2024-01-23 |
| InBios International, Inc. | 1 | 0 | 2024-08-23 |
| Becton, Dickinson and Company | 1 | 0 | 2025-06-16 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 1 | 2025-10-22 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 0 | 2025-06-13 |
| CorDx, Inc. | 1 | 1 | 2026-06-01 |
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 |
|---|---|---|---|---|
| 87426 | CPT | — | High | SARS-CoV-2 antigen or nucleic acid detection test, point-of-care methodology |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-06-01 | K253882 | CorDx, Inc. | CorDx Tyfast COVID-19 Ag Rapid Test Rx |
| 2025-10-22 | K251289 | Guangzhou Wondfo Biotech Co., Ltd. | WELLlife COVID-19 Antigen Test Rx |
| 2025-06-16 | K243872 | Becton, Dickinson and Company | BD Veritor System for SARS-CoV-2 |
| 2025-06-13 | K250273 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card |
| 2024-08-23 | K233358 | InBios International, Inc. | SCoV-2 Ag Detect Rapid Test |
| 2024-04-19 | K232377 | Healgen Scientific,, LLC | Healgen Rapid COVID-19 Antigen Test |
| 2024-01-23 | K231187 | Nano-Ditech Corporation | Nano-Check COVID-19 Antigen Test |
| 2023-12-13 | K233688 | Quidel Corporation | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set |
| 2023-03-08 | DEN220039 | Quidel Corporation | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set |